Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study.
BACKGROUND: Reducing bisphosphonate dosing frequency may improve suboptimal adherence to treatment and therefore therapeutic outcomes in postmenopausal osteoporosis. Once-monthly oral ibandronate has been developed to overcome this problem. OBJECTIVE: To confirm the 1 year results and provide more e...
| Principais autores: | , , , , , , , , , , , , , , , |
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| Formato: | Journal article |
| Idioma: | English |
| Publicado em: |
2006
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| _version_ | 1826302147186130944 |
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| author | Reginster, J Adami, S Lakatos, P Greenwald, M Stepan, J Silverman, S Christiansen, C Rowell, L Mairon, N Bonvoisin, B Drezner, M Emkey, R Felsenberg, D Cooper, C Delmas, P Miller, P |
| author_facet | Reginster, J Adami, S Lakatos, P Greenwald, M Stepan, J Silverman, S Christiansen, C Rowell, L Mairon, N Bonvoisin, B Drezner, M Emkey, R Felsenberg, D Cooper, C Delmas, P Miller, P |
| author_sort | Reginster, J |
| collection | OXFORD |
| description | BACKGROUND: Reducing bisphosphonate dosing frequency may improve suboptimal adherence to treatment and therefore therapeutic outcomes in postmenopausal osteoporosis. Once-monthly oral ibandronate has been developed to overcome this problem. OBJECTIVE: To confirm the 1 year results and provide more extensive safety and tolerability information for once-monthly dosing by a 2 year analysis. METHODS: MOBILE, a randomised, phase III, non-inferiority study, compared the efficacy and safety of once-monthly ibandronate with daily ibandronate, which has previously been shown to reduce vertebral fracture risk in comparison with placebo. RESULTS: 1609 postmenopausal women were randomised. Substantial increases in lumbar spine bone mineral density (BMD) were seen in all treatment arms: 5.0%, 5.3%, 5.6%, and 6.6% in the daily and once-monthly groups (50 + 50 mg, 100 mg, and 150 mg), respectively. It was confirmed that all once-monthly regimens were at least as effective as daily treatment, and in addition, 150 mg was found to be better (p<0.001). Substantial increases in proximal femur (total hip, femoral neck, trochanter) BMD were seen; 150 mg produced the most pronounced effect (p<0.05 versus daily treatment). Independent of the regimen, most participants (70.5-93.5%) achieved increases above baseline in lumbar spine or total hip BMD, or both. Pronounced decreases in the biochemical marker of bone resorption, sCTX, observed in all arms after 3 months, were maintained throughout. The 150 mg regimen consistently produced greater increases in BMD and sCTX suppression than the 100 mg and daily regimens. Ibandronate was well tolerated, with a similar incidence of adverse events across groups. CONCLUSIONS: Once-monthly oral ibandronate is at least as effective and well tolerated as daily treatment. Once-monthly administration may be more convenient for patients and improve therapeutic adherence, thereby optimising outcomes. |
| first_indexed | 2024-03-07T05:43:08Z |
| format | Journal article |
| id | oxford-uuid:e6452c93-cfb9-46b7-9d49-68ee6ee87cc1 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T05:43:08Z |
| publishDate | 2006 |
| record_format | dspace |
| spelling | oxford-uuid:e6452c93-cfb9-46b7-9d49-68ee6ee87cc12022-03-27T10:30:01ZEfficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:e6452c93-cfb9-46b7-9d49-68ee6ee87cc1EnglishSymplectic Elements at Oxford2006Reginster, JAdami, SLakatos, PGreenwald, MStepan, JSilverman, SChristiansen, CRowell, LMairon, NBonvoisin, BDrezner, MEmkey, RFelsenberg, DCooper, CDelmas, PMiller, PBACKGROUND: Reducing bisphosphonate dosing frequency may improve suboptimal adherence to treatment and therefore therapeutic outcomes in postmenopausal osteoporosis. Once-monthly oral ibandronate has been developed to overcome this problem. OBJECTIVE: To confirm the 1 year results and provide more extensive safety and tolerability information for once-monthly dosing by a 2 year analysis. METHODS: MOBILE, a randomised, phase III, non-inferiority study, compared the efficacy and safety of once-monthly ibandronate with daily ibandronate, which has previously been shown to reduce vertebral fracture risk in comparison with placebo. RESULTS: 1609 postmenopausal women were randomised. Substantial increases in lumbar spine bone mineral density (BMD) were seen in all treatment arms: 5.0%, 5.3%, 5.6%, and 6.6% in the daily and once-monthly groups (50 + 50 mg, 100 mg, and 150 mg), respectively. It was confirmed that all once-monthly regimens were at least as effective as daily treatment, and in addition, 150 mg was found to be better (p<0.001). Substantial increases in proximal femur (total hip, femoral neck, trochanter) BMD were seen; 150 mg produced the most pronounced effect (p<0.05 versus daily treatment). Independent of the regimen, most participants (70.5-93.5%) achieved increases above baseline in lumbar spine or total hip BMD, or both. Pronounced decreases in the biochemical marker of bone resorption, sCTX, observed in all arms after 3 months, were maintained throughout. The 150 mg regimen consistently produced greater increases in BMD and sCTX suppression than the 100 mg and daily regimens. Ibandronate was well tolerated, with a similar incidence of adverse events across groups. CONCLUSIONS: Once-monthly oral ibandronate is at least as effective and well tolerated as daily treatment. Once-monthly administration may be more convenient for patients and improve therapeutic adherence, thereby optimising outcomes. |
| spellingShingle | Reginster, J Adami, S Lakatos, P Greenwald, M Stepan, J Silverman, S Christiansen, C Rowell, L Mairon, N Bonvoisin, B Drezner, M Emkey, R Felsenberg, D Cooper, C Delmas, P Miller, P Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. |
| title | Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. |
| title_full | Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. |
| title_fullStr | Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. |
| title_full_unstemmed | Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. |
| title_short | Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. |
| title_sort | efficacy and tolerability of once monthly oral ibandronate in postmenopausal osteoporosis 2 year results from the mobile study |
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