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Efficacy of monthly oral ibandronate is sustained over 5 years: the MOBILE long-term extension study
- Source :
- Osteoporosis International. 23:1747-1756
- Publication Year :
- 2011
- Publisher :
- Springer Science and Business Media LLC, 2011.
-
Abstract
- The long-term efficacy and safety of once-monthly ibandronate were studied in this extension to the 2-year Monthly Oral Ibandronate in Ladies (MOBILE) trial. Over 5 years, lumbar spine bone mineral density (BMD) increased from baseline with monthly ibandronate 150 mg (8.4%). Long-term monthly ibandronate is effective and well tolerated for up to 5 years in women with postmenopausal osteoporosis.Once-monthly therapy with ibandronate has been studied for up to 5 years in a long-term extension (LTE) to the 2 year MOBILE trial.This multicenter, double-blind extension study of monthly ibandronate involved postmenopausal women who had completed 2 years of the MOBILE core study, with ≥75% adherence. Patients were reallocated, or were randomized from daily therapy, to ibandronate 100 mg monthly or 150 mg monthly for a further 3 years.A pooled intent-to-treat (ITT) analysis of 344 patients receiving monthly ibandronate from the core MOBILE baseline showed increases over 5 years in lumbar spine BMD (8.2% with 100 mg and 8.4% with 150 mg). Three-year data relative to MOBILE LTE baseline in the full ITT population of all 698 patients randomized or reallocated from MOBILE (including those previously on daily treatment) showed, on average, maintenance of proximal femur BMD gains achieved in the core 2-year study, with further small gains in lumbar spine BMD. In general, maintenance of efficacy was also indicated by markers of bone metabolism.There were no tolerability concerns or new safety signals. Monthly treatment with ibandronate 100 and 150 mg is effective and well tolerated for up to 5 years in women with postmenopausal osteoporosis.
- Subjects :
- musculoskeletal diseases
medicine.medical_specialty
Endocrinology, Diabetes and Metabolism
medicine.medical_treatment
Osteoporosis
Postmenopausal osteoporosis
Ibandronic acid
Bone remodeling
law.invention
Absorptiometry, Photon
Double-Blind Method
Randomized controlled trial
Bone Density
law
Internal medicine
medicine
Humans
Femur
Ibandronic Acid
Osteoporosis, Postmenopausal
Aged
Aged, 80 and over
Bone mineral
Lumbar Vertebrae
Bone Density Conservation Agents
Diphosphonates
business.industry
Extension study
Middle Aged
Bisphosphonate
medicine.disease
Treatment Outcome
Female
Bone Remodeling
business
Biomarkers
medicine.drug
Subjects
Details
- ISSN :
- 14332965 and 0937941X
- Volume :
- 23
- Database :
- OpenAIRE
- Journal :
- Osteoporosis International
- Accession number :
- edsair.doi.dedup.....a9cf7181ef51a54310a0d1d2f241e8b5
- Full Text :
- https://doi.org/10.1007/s00198-011-1773-0