Effects of Two Administration Schemes of Intramuscular Clodronic Acid on Bone Mineral Density
Abstract Background: Clodronic acid is a bisphosphonate used in the prevention and treatment of postmenopausal bone loss. Previous evidence suggests a direct dose-response relationship for the densitometric effect of clodronic acid. Therefore, as it is widely accepted that a reduction in the dosing...
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Gespeichert in:
| Autor*in: |
Frediani, Bruno [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2011 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: Clinical drug investigation - Berlin [u.a.] : Springer, 1989, 31(2011), 1 vom: Jan., Seite 43-50 |
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| Übergeordnetes Werk: |
volume:31 ; year:2011 ; number:1 ; month:01 ; pages:43-50 |
| Links: |
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| DOI / URN: |
10.2165/11539990-000000000-00000 |
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SPR033019169 |
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| 520 | |a Abstract Background: Clodronic acid is a bisphosphonate used in the prevention and treatment of postmenopausal bone loss. Previous evidence suggests a direct dose-response relationship for the densitometric effect of clodronic acid. Therefore, as it is widely accepted that a reduction in the dosing frequency of bisphosphonates may improve adherence and therefore therapeutic outcomes, an increase in the interval between consecutive administrations of clodronic acid might be associated with a concomitant increase in the overall bisphosphonate dose received. However, to our knowledge, a direct comparison of the effects of intramuscular clodronic acid 100 mg once weekly with a regimen consisting of a higher dose and a longer interval between two consecutive administrations is still lacking. Objective: This study compared the increase in bone mineral density (BMD) achieved with two different administration schemes of intramuscular clodronic acid (100 mg once weekly and 200 mg every 2 weeks) in patients with postmenopausal osteoporosis. Study Design and Setting: This randomized, open-label, parallel-group trial was conducted in the Osteoporosis and Instrumental Diagnosis Center ‘OsteoArticolar’ (University of Siena, Siena, Italy) between January 2007 and December 2009. Patients: Consecutive women aged 50–80 years with postmenopausal osteoporosis, diagnosed ≥5 years prior to inclusion in the study, were eligible for participation in this study. Intervention: Patients were randomized to receive either intramuscular clodronic acid (Clasteon®) 100 mg (group A) + lidocaine (lignocaine) once weekly or intramuscular clodronic acid 100mg+lidocaine for two consecutive days every 2 weeks (group B), for 2 years. Results: In total, 30 patients were randomized to group A and 30 patients to group B. Significant increases in mean ±SD BMD of the lumbar spine versus baseline values were observed in both groups at 1 and 2 year(s) from treatment initiation (group A —year 1: +2.8%±1.7%, p<0.05; year 2: +3.5% ±f-2.2%, p < 0.01; group B —year 1: +2.7% ±2.1 %, p < 0.05; year 2: +3.9% ±2.2%, p<0.01). Mean ±SD BMD at the femoral neck also significantly increased versus baseline in group A at both timepoints (year 1: +2.3% ±1.9%, p < 0.05; year 2: +2.5% ±1.9%, p < 0.05), while the increase reported in group B was significant only after 2 years of treatment (year 1: +1.9% ±2.2%; year 2: +2.8% ±1.8%; p<0.05). Significant mean ±SD increases in total femur BMD were observed only in group A at 2 years (+2.4%±1.9, p<0.05). No differences between study groups were reported. Two non-traumatic vertebral fractures were observed in group A (6.6%) and three in group B (10.0%). Treatment was well tolerated; mild pain at injection site was observed in three patients (one in group A, 3.3%; two in group B, 6.6%). Conclusion: This randomized study suggests, for the first time to the author’s knowledge, a similar effect of intramuscular clodronic acid 100mg once weekly and 200mg every 2 weeks (two 100mg administrations on two consecutive days) on BMD in women with postmenopausal osteoporosis. The administration of intramuscular clodronic acid 200 mg every 2 weeks may therefore represent a new therapeutic option in the treatment of postmenopausal osteoporosis. | ||
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| 650 | 4 | |a Femoral Bone Mineral Density |7 (dpeaa)DE-He213 | |
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10.2165/11539990-000000000-00000 doi (DE-627)SPR033019169 (SPR)11539990-000000000-00000-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Frediani, Bruno verfasserin aut Effects of Two Administration Schemes of Intramuscular Clodronic Acid on Bone Mineral Density 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background: Clodronic acid is a bisphosphonate used in the prevention and treatment of postmenopausal bone loss. Previous evidence suggests a direct dose-response relationship for the densitometric effect of clodronic acid. Therefore, as it is widely accepted that a reduction in the dosing frequency of bisphosphonates may improve adherence and therefore therapeutic outcomes, an increase in the interval between consecutive administrations of clodronic acid might be associated with a concomitant increase in the overall bisphosphonate dose received. However, to our knowledge, a direct comparison of the effects of intramuscular clodronic acid 100 mg once weekly with a regimen consisting of a higher dose and a longer interval between two consecutive administrations is still lacking. Objective: This study compared the increase in bone mineral density (BMD) achieved with two different administration schemes of intramuscular clodronic acid (100 mg once weekly and 200 mg every 2 weeks) in patients with postmenopausal osteoporosis. Study Design and Setting: This randomized, open-label, parallel-group trial was conducted in the Osteoporosis and Instrumental Diagnosis Center ‘OsteoArticolar’ (University of Siena, Siena, Italy) between January 2007 and December 2009. Patients: Consecutive women aged 50–80 years with postmenopausal osteoporosis, diagnosed ≥5 years prior to inclusion in the study, were eligible for participation in this study. Intervention: Patients were randomized to receive either intramuscular clodronic acid (Clasteon®) 100 mg (group A) + lidocaine (lignocaine) once weekly or intramuscular clodronic acid 100mg+lidocaine for two consecutive days every 2 weeks (group B), for 2 years. Results: In total, 30 patients were randomized to group A and 30 patients to group B. Significant increases in mean ±SD BMD of the lumbar spine versus baseline values were observed in both groups at 1 and 2 year(s) from treatment initiation (group A —year 1: +2.8%±1.7%, p<0.05; year 2: +3.5% ±f-2.2%, p < 0.01; group B —year 1: +2.7% ±2.1 %, p < 0.05; year 2: +3.9% ±2.2%, p<0.01). Mean ±SD BMD at the femoral neck also significantly increased versus baseline in group A at both timepoints (year 1: +2.3% ±1.9%, p < 0.05; year 2: +2.5% ±1.9%, p < 0.05), while the increase reported in group B was significant only after 2 years of treatment (year 1: +1.9% ±2.2%; year 2: +2.8% ±1.8%; p<0.05). Significant mean ±SD increases in total femur BMD were observed only in group A at 2 years (+2.4%±1.9, p<0.05). No differences between study groups were reported. Two non-traumatic vertebral fractures were observed in group A (6.6%) and three in group B (10.0%). Treatment was well tolerated; mild pain at injection site was observed in three patients (one in group A, 3.3%; two in group B, 6.6%). Conclusion: This randomized study suggests, for the first time to the author’s knowledge, a similar effect of intramuscular clodronic acid 100mg once weekly and 200mg every 2 weeks (two 100mg administrations on two consecutive days) on BMD in women with postmenopausal osteoporosis. The administration of intramuscular clodronic acid 200 mg every 2 weeks may therefore represent a new therapeutic option in the treatment of postmenopausal osteoporosis. Bone Mineral Density (dpeaa)DE-He213 Lumbar Spine (dpeaa)DE-He213 Postmenopausal Osteoporosis (dpeaa)DE-He213 Bisphosphonate Treatment (dpeaa)DE-He213 Femoral Bone Mineral Density (dpeaa)DE-He213 Enthalten in Clinical drug investigation Berlin [u.a.] : Springer, 1989 31(2011), 1 vom: Jan., Seite 43-50 (DE-627)327645083 (DE-600)2043793-6 1179-1918 nnns volume:31 year:2011 number:1 month:01 pages:43-50 https://dx.doi.org/10.2165/11539990-000000000-00000 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 ASE AR 31 2011 1 01 43-50 |
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10.2165/11539990-000000000-00000 doi (DE-627)SPR033019169 (SPR)11539990-000000000-00000-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Frediani, Bruno verfasserin aut Effects of Two Administration Schemes of Intramuscular Clodronic Acid on Bone Mineral Density 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background: Clodronic acid is a bisphosphonate used in the prevention and treatment of postmenopausal bone loss. Previous evidence suggests a direct dose-response relationship for the densitometric effect of clodronic acid. Therefore, as it is widely accepted that a reduction in the dosing frequency of bisphosphonates may improve adherence and therefore therapeutic outcomes, an increase in the interval between consecutive administrations of clodronic acid might be associated with a concomitant increase in the overall bisphosphonate dose received. However, to our knowledge, a direct comparison of the effects of intramuscular clodronic acid 100 mg once weekly with a regimen consisting of a higher dose and a longer interval between two consecutive administrations is still lacking. Objective: This study compared the increase in bone mineral density (BMD) achieved with two different administration schemes of intramuscular clodronic acid (100 mg once weekly and 200 mg every 2 weeks) in patients with postmenopausal osteoporosis. Study Design and Setting: This randomized, open-label, parallel-group trial was conducted in the Osteoporosis and Instrumental Diagnosis Center ‘OsteoArticolar’ (University of Siena, Siena, Italy) between January 2007 and December 2009. Patients: Consecutive women aged 50–80 years with postmenopausal osteoporosis, diagnosed ≥5 years prior to inclusion in the study, were eligible for participation in this study. Intervention: Patients were randomized to receive either intramuscular clodronic acid (Clasteon®) 100 mg (group A) + lidocaine (lignocaine) once weekly or intramuscular clodronic acid 100mg+lidocaine for two consecutive days every 2 weeks (group B), for 2 years. Results: In total, 30 patients were randomized to group A and 30 patients to group B. Significant increases in mean ±SD BMD of the lumbar spine versus baseline values were observed in both groups at 1 and 2 year(s) from treatment initiation (group A —year 1: +2.8%±1.7%, p<0.05; year 2: +3.5% ±f-2.2%, p < 0.01; group B —year 1: +2.7% ±2.1 %, p < 0.05; year 2: +3.9% ±2.2%, p<0.01). Mean ±SD BMD at the femoral neck also significantly increased versus baseline in group A at both timepoints (year 1: +2.3% ±1.9%, p < 0.05; year 2: +2.5% ±1.9%, p < 0.05), while the increase reported in group B was significant only after 2 years of treatment (year 1: +1.9% ±2.2%; year 2: +2.8% ±1.8%; p<0.05). Significant mean ±SD increases in total femur BMD were observed only in group A at 2 years (+2.4%±1.9, p<0.05). No differences between study groups were reported. Two non-traumatic vertebral fractures were observed in group A (6.6%) and three in group B (10.0%). Treatment was well tolerated; mild pain at injection site was observed in three patients (one in group A, 3.3%; two in group B, 6.6%). Conclusion: This randomized study suggests, for the first time to the author’s knowledge, a similar effect of intramuscular clodronic acid 100mg once weekly and 200mg every 2 weeks (two 100mg administrations on two consecutive days) on BMD in women with postmenopausal osteoporosis. The administration of intramuscular clodronic acid 200 mg every 2 weeks may therefore represent a new therapeutic option in the treatment of postmenopausal osteoporosis. Bone Mineral Density (dpeaa)DE-He213 Lumbar Spine (dpeaa)DE-He213 Postmenopausal Osteoporosis (dpeaa)DE-He213 Bisphosphonate Treatment (dpeaa)DE-He213 Femoral Bone Mineral Density (dpeaa)DE-He213 Enthalten in Clinical drug investigation Berlin [u.a.] : Springer, 1989 31(2011), 1 vom: Jan., Seite 43-50 (DE-627)327645083 (DE-600)2043793-6 1179-1918 nnns volume:31 year:2011 number:1 month:01 pages:43-50 https://dx.doi.org/10.2165/11539990-000000000-00000 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 ASE AR 31 2011 1 01 43-50 |
| allfields_unstemmed |
10.2165/11539990-000000000-00000 doi (DE-627)SPR033019169 (SPR)11539990-000000000-00000-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Frediani, Bruno verfasserin aut Effects of Two Administration Schemes of Intramuscular Clodronic Acid on Bone Mineral Density 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background: Clodronic acid is a bisphosphonate used in the prevention and treatment of postmenopausal bone loss. Previous evidence suggests a direct dose-response relationship for the densitometric effect of clodronic acid. Therefore, as it is widely accepted that a reduction in the dosing frequency of bisphosphonates may improve adherence and therefore therapeutic outcomes, an increase in the interval between consecutive administrations of clodronic acid might be associated with a concomitant increase in the overall bisphosphonate dose received. However, to our knowledge, a direct comparison of the effects of intramuscular clodronic acid 100 mg once weekly with a regimen consisting of a higher dose and a longer interval between two consecutive administrations is still lacking. Objective: This study compared the increase in bone mineral density (BMD) achieved with two different administration schemes of intramuscular clodronic acid (100 mg once weekly and 200 mg every 2 weeks) in patients with postmenopausal osteoporosis. Study Design and Setting: This randomized, open-label, parallel-group trial was conducted in the Osteoporosis and Instrumental Diagnosis Center ‘OsteoArticolar’ (University of Siena, Siena, Italy) between January 2007 and December 2009. Patients: Consecutive women aged 50–80 years with postmenopausal osteoporosis, diagnosed ≥5 years prior to inclusion in the study, were eligible for participation in this study. Intervention: Patients were randomized to receive either intramuscular clodronic acid (Clasteon®) 100 mg (group A) + lidocaine (lignocaine) once weekly or intramuscular clodronic acid 100mg+lidocaine for two consecutive days every 2 weeks (group B), for 2 years. Results: In total, 30 patients were randomized to group A and 30 patients to group B. Significant increases in mean ±SD BMD of the lumbar spine versus baseline values were observed in both groups at 1 and 2 year(s) from treatment initiation (group A —year 1: +2.8%±1.7%, p<0.05; year 2: +3.5% ±f-2.2%, p < 0.01; group B —year 1: +2.7% ±2.1 %, p < 0.05; year 2: +3.9% ±2.2%, p<0.01). Mean ±SD BMD at the femoral neck also significantly increased versus baseline in group A at both timepoints (year 1: +2.3% ±1.9%, p < 0.05; year 2: +2.5% ±1.9%, p < 0.05), while the increase reported in group B was significant only after 2 years of treatment (year 1: +1.9% ±2.2%; year 2: +2.8% ±1.8%; p<0.05). Significant mean ±SD increases in total femur BMD were observed only in group A at 2 years (+2.4%±1.9, p<0.05). No differences between study groups were reported. Two non-traumatic vertebral fractures were observed in group A (6.6%) and three in group B (10.0%). Treatment was well tolerated; mild pain at injection site was observed in three patients (one in group A, 3.3%; two in group B, 6.6%). Conclusion: This randomized study suggests, for the first time to the author’s knowledge, a similar effect of intramuscular clodronic acid 100mg once weekly and 200mg every 2 weeks (two 100mg administrations on two consecutive days) on BMD in women with postmenopausal osteoporosis. The administration of intramuscular clodronic acid 200 mg every 2 weeks may therefore represent a new therapeutic option in the treatment of postmenopausal osteoporosis. Bone Mineral Density (dpeaa)DE-He213 Lumbar Spine (dpeaa)DE-He213 Postmenopausal Osteoporosis (dpeaa)DE-He213 Bisphosphonate Treatment (dpeaa)DE-He213 Femoral Bone Mineral Density (dpeaa)DE-He213 Enthalten in Clinical drug investigation Berlin [u.a.] : Springer, 1989 31(2011), 1 vom: Jan., Seite 43-50 (DE-627)327645083 (DE-600)2043793-6 1179-1918 nnns volume:31 year:2011 number:1 month:01 pages:43-50 https://dx.doi.org/10.2165/11539990-000000000-00000 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 ASE AR 31 2011 1 01 43-50 |
| allfieldsGer |
10.2165/11539990-000000000-00000 doi (DE-627)SPR033019169 (SPR)11539990-000000000-00000-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Frediani, Bruno verfasserin aut Effects of Two Administration Schemes of Intramuscular Clodronic Acid on Bone Mineral Density 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background: Clodronic acid is a bisphosphonate used in the prevention and treatment of postmenopausal bone loss. Previous evidence suggests a direct dose-response relationship for the densitometric effect of clodronic acid. Therefore, as it is widely accepted that a reduction in the dosing frequency of bisphosphonates may improve adherence and therefore therapeutic outcomes, an increase in the interval between consecutive administrations of clodronic acid might be associated with a concomitant increase in the overall bisphosphonate dose received. However, to our knowledge, a direct comparison of the effects of intramuscular clodronic acid 100 mg once weekly with a regimen consisting of a higher dose and a longer interval between two consecutive administrations is still lacking. Objective: This study compared the increase in bone mineral density (BMD) achieved with two different administration schemes of intramuscular clodronic acid (100 mg once weekly and 200 mg every 2 weeks) in patients with postmenopausal osteoporosis. Study Design and Setting: This randomized, open-label, parallel-group trial was conducted in the Osteoporosis and Instrumental Diagnosis Center ‘OsteoArticolar’ (University of Siena, Siena, Italy) between January 2007 and December 2009. Patients: Consecutive women aged 50–80 years with postmenopausal osteoporosis, diagnosed ≥5 years prior to inclusion in the study, were eligible for participation in this study. Intervention: Patients were randomized to receive either intramuscular clodronic acid (Clasteon®) 100 mg (group A) + lidocaine (lignocaine) once weekly or intramuscular clodronic acid 100mg+lidocaine for two consecutive days every 2 weeks (group B), for 2 years. Results: In total, 30 patients were randomized to group A and 30 patients to group B. Significant increases in mean ±SD BMD of the lumbar spine versus baseline values were observed in both groups at 1 and 2 year(s) from treatment initiation (group A —year 1: +2.8%±1.7%, p<0.05; year 2: +3.5% ±f-2.2%, p < 0.01; group B —year 1: +2.7% ±2.1 %, p < 0.05; year 2: +3.9% ±2.2%, p<0.01). Mean ±SD BMD at the femoral neck also significantly increased versus baseline in group A at both timepoints (year 1: +2.3% ±1.9%, p < 0.05; year 2: +2.5% ±1.9%, p < 0.05), while the increase reported in group B was significant only after 2 years of treatment (year 1: +1.9% ±2.2%; year 2: +2.8% ±1.8%; p<0.05). Significant mean ±SD increases in total femur BMD were observed only in group A at 2 years (+2.4%±1.9, p<0.05). No differences between study groups were reported. Two non-traumatic vertebral fractures were observed in group A (6.6%) and three in group B (10.0%). Treatment was well tolerated; mild pain at injection site was observed in three patients (one in group A, 3.3%; two in group B, 6.6%). Conclusion: This randomized study suggests, for the first time to the author’s knowledge, a similar effect of intramuscular clodronic acid 100mg once weekly and 200mg every 2 weeks (two 100mg administrations on two consecutive days) on BMD in women with postmenopausal osteoporosis. The administration of intramuscular clodronic acid 200 mg every 2 weeks may therefore represent a new therapeutic option in the treatment of postmenopausal osteoporosis. Bone Mineral Density (dpeaa)DE-He213 Lumbar Spine (dpeaa)DE-He213 Postmenopausal Osteoporosis (dpeaa)DE-He213 Bisphosphonate Treatment (dpeaa)DE-He213 Femoral Bone Mineral Density (dpeaa)DE-He213 Enthalten in Clinical drug investigation Berlin [u.a.] : Springer, 1989 31(2011), 1 vom: Jan., Seite 43-50 (DE-627)327645083 (DE-600)2043793-6 1179-1918 nnns volume:31 year:2011 number:1 month:01 pages:43-50 https://dx.doi.org/10.2165/11539990-000000000-00000 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 ASE AR 31 2011 1 01 43-50 |
| allfieldsSound |
10.2165/11539990-000000000-00000 doi (DE-627)SPR033019169 (SPR)11539990-000000000-00000-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Frediani, Bruno verfasserin aut Effects of Two Administration Schemes of Intramuscular Clodronic Acid on Bone Mineral Density 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background: Clodronic acid is a bisphosphonate used in the prevention and treatment of postmenopausal bone loss. Previous evidence suggests a direct dose-response relationship for the densitometric effect of clodronic acid. Therefore, as it is widely accepted that a reduction in the dosing frequency of bisphosphonates may improve adherence and therefore therapeutic outcomes, an increase in the interval between consecutive administrations of clodronic acid might be associated with a concomitant increase in the overall bisphosphonate dose received. However, to our knowledge, a direct comparison of the effects of intramuscular clodronic acid 100 mg once weekly with a regimen consisting of a higher dose and a longer interval between two consecutive administrations is still lacking. Objective: This study compared the increase in bone mineral density (BMD) achieved with two different administration schemes of intramuscular clodronic acid (100 mg once weekly and 200 mg every 2 weeks) in patients with postmenopausal osteoporosis. Study Design and Setting: This randomized, open-label, parallel-group trial was conducted in the Osteoporosis and Instrumental Diagnosis Center ‘OsteoArticolar’ (University of Siena, Siena, Italy) between January 2007 and December 2009. Patients: Consecutive women aged 50–80 years with postmenopausal osteoporosis, diagnosed ≥5 years prior to inclusion in the study, were eligible for participation in this study. Intervention: Patients were randomized to receive either intramuscular clodronic acid (Clasteon®) 100 mg (group A) + lidocaine (lignocaine) once weekly or intramuscular clodronic acid 100mg+lidocaine for two consecutive days every 2 weeks (group B), for 2 years. Results: In total, 30 patients were randomized to group A and 30 patients to group B. Significant increases in mean ±SD BMD of the lumbar spine versus baseline values were observed in both groups at 1 and 2 year(s) from treatment initiation (group A —year 1: +2.8%±1.7%, p<0.05; year 2: +3.5% ±f-2.2%, p < 0.01; group B —year 1: +2.7% ±2.1 %, p < 0.05; year 2: +3.9% ±2.2%, p<0.01). Mean ±SD BMD at the femoral neck also significantly increased versus baseline in group A at both timepoints (year 1: +2.3% ±1.9%, p < 0.05; year 2: +2.5% ±1.9%, p < 0.05), while the increase reported in group B was significant only after 2 years of treatment (year 1: +1.9% ±2.2%; year 2: +2.8% ±1.8%; p<0.05). Significant mean ±SD increases in total femur BMD were observed only in group A at 2 years (+2.4%±1.9, p<0.05). No differences between study groups were reported. Two non-traumatic vertebral fractures were observed in group A (6.6%) and three in group B (10.0%). Treatment was well tolerated; mild pain at injection site was observed in three patients (one in group A, 3.3%; two in group B, 6.6%). Conclusion: This randomized study suggests, for the first time to the author’s knowledge, a similar effect of intramuscular clodronic acid 100mg once weekly and 200mg every 2 weeks (two 100mg administrations on two consecutive days) on BMD in women with postmenopausal osteoporosis. The administration of intramuscular clodronic acid 200 mg every 2 weeks may therefore represent a new therapeutic option in the treatment of postmenopausal osteoporosis. Bone Mineral Density (dpeaa)DE-He213 Lumbar Spine (dpeaa)DE-He213 Postmenopausal Osteoporosis (dpeaa)DE-He213 Bisphosphonate Treatment (dpeaa)DE-He213 Femoral Bone Mineral Density (dpeaa)DE-He213 Enthalten in Clinical drug investigation Berlin [u.a.] : Springer, 1989 31(2011), 1 vom: Jan., Seite 43-50 (DE-627)327645083 (DE-600)2043793-6 1179-1918 nnns volume:31 year:2011 number:1 month:01 pages:43-50 https://dx.doi.org/10.2165/11539990-000000000-00000 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 ASE AR 31 2011 1 01 43-50 |
| language |
English |
| source |
Enthalten in Clinical drug investigation 31(2011), 1 vom: Jan., Seite 43-50 volume:31 year:2011 number:1 month:01 pages:43-50 |
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Bone Mineral Density Lumbar Spine Postmenopausal Osteoporosis Bisphosphonate Treatment Femoral Bone Mineral Density |
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Frediani, Bruno @@aut@@ |
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2011-01-01T00:00:00Z |
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3610 |
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SPR033019169 |
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englisch |
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Previous evidence suggests a direct dose-response relationship for the densitometric effect of clodronic acid. Therefore, as it is widely accepted that a reduction in the dosing frequency of bisphosphonates may improve adherence and therefore therapeutic outcomes, an increase in the interval between consecutive administrations of clodronic acid might be associated with a concomitant increase in the overall bisphosphonate dose received. However, to our knowledge, a direct comparison of the effects of intramuscular clodronic acid 100 mg once weekly with a regimen consisting of a higher dose and a longer interval between two consecutive administrations is still lacking. Objective: This study compared the increase in bone mineral density (BMD) achieved with two different administration schemes of intramuscular clodronic acid (100 mg once weekly and 200 mg every 2 weeks) in patients with postmenopausal osteoporosis. Study Design and Setting: This randomized, open-label, parallel-group trial was conducted in the Osteoporosis and Instrumental Diagnosis Center ‘OsteoArticolar’ (University of Siena, Siena, Italy) between January 2007 and December 2009. Patients: Consecutive women aged 50–80 years with postmenopausal osteoporosis, diagnosed ≥5 years prior to inclusion in the study, were eligible for participation in this study. Intervention: Patients were randomized to receive either intramuscular clodronic acid (Clasteon®) 100 mg (group A) + lidocaine (lignocaine) once weekly or intramuscular clodronic acid 100mg+lidocaine for two consecutive days every 2 weeks (group B), for 2 years. Results: In total, 30 patients were randomized to group A and 30 patients to group B. Significant increases in mean ±SD BMD of the lumbar spine versus baseline values were observed in both groups at 1 and 2 year(s) from treatment initiation (group A —year 1: +2.8%±1.7%, p<0.05; year 2: +3.5% ±f-2.2%, p < 0.01; group B —year 1: +2.7% ±2.1 %, p < 0.05; year 2: +3.9% ±2.2%, p<0.01). Mean ±SD BMD at the femoral neck also significantly increased versus baseline in group A at both timepoints (year 1: +2.3% ±1.9%, p < 0.05; year 2: +2.5% ±1.9%, p < 0.05), while the increase reported in group B was significant only after 2 years of treatment (year 1: +1.9% ±2.2%; year 2: +2.8% ±1.8%; p<0.05). Significant mean ±SD increases in total femur BMD were observed only in group A at 2 years (+2.4%±1.9, p<0.05). No differences between study groups were reported. Two non-traumatic vertebral fractures were observed in group A (6.6%) and three in group B (10.0%). Treatment was well tolerated; mild pain at injection site was observed in three patients (one in group A, 3.3%; two in group B, 6.6%). Conclusion: This randomized study suggests, for the first time to the author’s knowledge, a similar effect of intramuscular clodronic acid 100mg once weekly and 200mg every 2 weeks (two 100mg administrations on two consecutive days) on BMD in women with postmenopausal osteoporosis. 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Frediani, Bruno |
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Frediani, Bruno ddc 610 bkl 44.40 misc Bone Mineral Density misc Lumbar Spine misc Postmenopausal Osteoporosis misc Bisphosphonate Treatment misc Femoral Bone Mineral Density Effects of Two Administration Schemes of Intramuscular Clodronic Acid on Bone Mineral Density |
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610 ASE 44.40 bkl Effects of Two Administration Schemes of Intramuscular Clodronic Acid on Bone Mineral Density Bone Mineral Density (dpeaa)DE-He213 Lumbar Spine (dpeaa)DE-He213 Postmenopausal Osteoporosis (dpeaa)DE-He213 Bisphosphonate Treatment (dpeaa)DE-He213 Femoral Bone Mineral Density (dpeaa)DE-He213 |
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Effects of Two Administration Schemes of Intramuscular Clodronic Acid on Bone Mineral Density |
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Effects of Two Administration Schemes of Intramuscular Clodronic Acid on Bone Mineral Density |
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Frediani, Bruno |
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Clinical drug investigation |
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Frediani, Bruno |
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10.2165/11539990-000000000-00000 |
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610 |
| title_sort |
effects of two administration schemes of intramuscular clodronic acid on bone mineral density |
| title_auth |
Effects of Two Administration Schemes of Intramuscular Clodronic Acid on Bone Mineral Density |
| abstract |
Abstract Background: Clodronic acid is a bisphosphonate used in the prevention and treatment of postmenopausal bone loss. Previous evidence suggests a direct dose-response relationship for the densitometric effect of clodronic acid. Therefore, as it is widely accepted that a reduction in the dosing frequency of bisphosphonates may improve adherence and therefore therapeutic outcomes, an increase in the interval between consecutive administrations of clodronic acid might be associated with a concomitant increase in the overall bisphosphonate dose received. However, to our knowledge, a direct comparison of the effects of intramuscular clodronic acid 100 mg once weekly with a regimen consisting of a higher dose and a longer interval between two consecutive administrations is still lacking. Objective: This study compared the increase in bone mineral density (BMD) achieved with two different administration schemes of intramuscular clodronic acid (100 mg once weekly and 200 mg every 2 weeks) in patients with postmenopausal osteoporosis. Study Design and Setting: This randomized, open-label, parallel-group trial was conducted in the Osteoporosis and Instrumental Diagnosis Center ‘OsteoArticolar’ (University of Siena, Siena, Italy) between January 2007 and December 2009. Patients: Consecutive women aged 50–80 years with postmenopausal osteoporosis, diagnosed ≥5 years prior to inclusion in the study, were eligible for participation in this study. Intervention: Patients were randomized to receive either intramuscular clodronic acid (Clasteon®) 100 mg (group A) + lidocaine (lignocaine) once weekly or intramuscular clodronic acid 100mg+lidocaine for two consecutive days every 2 weeks (group B), for 2 years. Results: In total, 30 patients were randomized to group A and 30 patients to group B. Significant increases in mean ±SD BMD of the lumbar spine versus baseline values were observed in both groups at 1 and 2 year(s) from treatment initiation (group A —year 1: +2.8%±1.7%, p<0.05; year 2: +3.5% ±f-2.2%, p < 0.01; group B —year 1: +2.7% ±2.1 %, p < 0.05; year 2: +3.9% ±2.2%, p<0.01). Mean ±SD BMD at the femoral neck also significantly increased versus baseline in group A at both timepoints (year 1: +2.3% ±1.9%, p < 0.05; year 2: +2.5% ±1.9%, p < 0.05), while the increase reported in group B was significant only after 2 years of treatment (year 1: +1.9% ±2.2%; year 2: +2.8% ±1.8%; p<0.05). Significant mean ±SD increases in total femur BMD were observed only in group A at 2 years (+2.4%±1.9, p<0.05). No differences between study groups were reported. Two non-traumatic vertebral fractures were observed in group A (6.6%) and three in group B (10.0%). Treatment was well tolerated; mild pain at injection site was observed in three patients (one in group A, 3.3%; two in group B, 6.6%). Conclusion: This randomized study suggests, for the first time to the author’s knowledge, a similar effect of intramuscular clodronic acid 100mg once weekly and 200mg every 2 weeks (two 100mg administrations on two consecutive days) on BMD in women with postmenopausal osteoporosis. The administration of intramuscular clodronic acid 200 mg every 2 weeks may therefore represent a new therapeutic option in the treatment of postmenopausal osteoporosis. |
| abstractGer |
Abstract Background: Clodronic acid is a bisphosphonate used in the prevention and treatment of postmenopausal bone loss. Previous evidence suggests a direct dose-response relationship for the densitometric effect of clodronic acid. Therefore, as it is widely accepted that a reduction in the dosing frequency of bisphosphonates may improve adherence and therefore therapeutic outcomes, an increase in the interval between consecutive administrations of clodronic acid might be associated with a concomitant increase in the overall bisphosphonate dose received. However, to our knowledge, a direct comparison of the effects of intramuscular clodronic acid 100 mg once weekly with a regimen consisting of a higher dose and a longer interval between two consecutive administrations is still lacking. Objective: This study compared the increase in bone mineral density (BMD) achieved with two different administration schemes of intramuscular clodronic acid (100 mg once weekly and 200 mg every 2 weeks) in patients with postmenopausal osteoporosis. Study Design and Setting: This randomized, open-label, parallel-group trial was conducted in the Osteoporosis and Instrumental Diagnosis Center ‘OsteoArticolar’ (University of Siena, Siena, Italy) between January 2007 and December 2009. Patients: Consecutive women aged 50–80 years with postmenopausal osteoporosis, diagnosed ≥5 years prior to inclusion in the study, were eligible for participation in this study. Intervention: Patients were randomized to receive either intramuscular clodronic acid (Clasteon®) 100 mg (group A) + lidocaine (lignocaine) once weekly or intramuscular clodronic acid 100mg+lidocaine for two consecutive days every 2 weeks (group B), for 2 years. Results: In total, 30 patients were randomized to group A and 30 patients to group B. Significant increases in mean ±SD BMD of the lumbar spine versus baseline values were observed in both groups at 1 and 2 year(s) from treatment initiation (group A —year 1: +2.8%±1.7%, p<0.05; year 2: +3.5% ±f-2.2%, p < 0.01; group B —year 1: +2.7% ±2.1 %, p < 0.05; year 2: +3.9% ±2.2%, p<0.01). Mean ±SD BMD at the femoral neck also significantly increased versus baseline in group A at both timepoints (year 1: +2.3% ±1.9%, p < 0.05; year 2: +2.5% ±1.9%, p < 0.05), while the increase reported in group B was significant only after 2 years of treatment (year 1: +1.9% ±2.2%; year 2: +2.8% ±1.8%; p<0.05). Significant mean ±SD increases in total femur BMD were observed only in group A at 2 years (+2.4%±1.9, p<0.05). No differences between study groups were reported. Two non-traumatic vertebral fractures were observed in group A (6.6%) and three in group B (10.0%). Treatment was well tolerated; mild pain at injection site was observed in three patients (one in group A, 3.3%; two in group B, 6.6%). Conclusion: This randomized study suggests, for the first time to the author’s knowledge, a similar effect of intramuscular clodronic acid 100mg once weekly and 200mg every 2 weeks (two 100mg administrations on two consecutive days) on BMD in women with postmenopausal osteoporosis. The administration of intramuscular clodronic acid 200 mg every 2 weeks may therefore represent a new therapeutic option in the treatment of postmenopausal osteoporosis. |
| abstract_unstemmed |
Abstract Background: Clodronic acid is a bisphosphonate used in the prevention and treatment of postmenopausal bone loss. Previous evidence suggests a direct dose-response relationship for the densitometric effect of clodronic acid. Therefore, as it is widely accepted that a reduction in the dosing frequency of bisphosphonates may improve adherence and therefore therapeutic outcomes, an increase in the interval between consecutive administrations of clodronic acid might be associated with a concomitant increase in the overall bisphosphonate dose received. However, to our knowledge, a direct comparison of the effects of intramuscular clodronic acid 100 mg once weekly with a regimen consisting of a higher dose and a longer interval between two consecutive administrations is still lacking. Objective: This study compared the increase in bone mineral density (BMD) achieved with two different administration schemes of intramuscular clodronic acid (100 mg once weekly and 200 mg every 2 weeks) in patients with postmenopausal osteoporosis. Study Design and Setting: This randomized, open-label, parallel-group trial was conducted in the Osteoporosis and Instrumental Diagnosis Center ‘OsteoArticolar’ (University of Siena, Siena, Italy) between January 2007 and December 2009. Patients: Consecutive women aged 50–80 years with postmenopausal osteoporosis, diagnosed ≥5 years prior to inclusion in the study, were eligible for participation in this study. Intervention: Patients were randomized to receive either intramuscular clodronic acid (Clasteon®) 100 mg (group A) + lidocaine (lignocaine) once weekly or intramuscular clodronic acid 100mg+lidocaine for two consecutive days every 2 weeks (group B), for 2 years. Results: In total, 30 patients were randomized to group A and 30 patients to group B. Significant increases in mean ±SD BMD of the lumbar spine versus baseline values were observed in both groups at 1 and 2 year(s) from treatment initiation (group A —year 1: +2.8%±1.7%, p<0.05; year 2: +3.5% ±f-2.2%, p < 0.01; group B —year 1: +2.7% ±2.1 %, p < 0.05; year 2: +3.9% ±2.2%, p<0.01). Mean ±SD BMD at the femoral neck also significantly increased versus baseline in group A at both timepoints (year 1: +2.3% ±1.9%, p < 0.05; year 2: +2.5% ±1.9%, p < 0.05), while the increase reported in group B was significant only after 2 years of treatment (year 1: +1.9% ±2.2%; year 2: +2.8% ±1.8%; p<0.05). Significant mean ±SD increases in total femur BMD were observed only in group A at 2 years (+2.4%±1.9, p<0.05). No differences between study groups were reported. Two non-traumatic vertebral fractures were observed in group A (6.6%) and three in group B (10.0%). Treatment was well tolerated; mild pain at injection site was observed in three patients (one in group A, 3.3%; two in group B, 6.6%). Conclusion: This randomized study suggests, for the first time to the author’s knowledge, a similar effect of intramuscular clodronic acid 100mg once weekly and 200mg every 2 weeks (two 100mg administrations on two consecutive days) on BMD in women with postmenopausal osteoporosis. The administration of intramuscular clodronic acid 200 mg every 2 weeks may therefore represent a new therapeutic option in the treatment of postmenopausal osteoporosis. |
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Effects of Two Administration Schemes of Intramuscular Clodronic Acid on Bone Mineral Density |
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| score |
7.400899 |