  Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE studyReginster, Jean-Yves  ; ; et alin Annals of the Rheumatic Diseases (2006), 65(5), 654-661 BACKGROUND: Reducing bisphosphonate dosing frequency may improve suboptimal adherence to treatment and therefore therapeutic outcomes in postmenopausal osteoporosis. Once-monthly oral ibandronate has been ... [more ▼] 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. [less ▲] Detailed reference viewed: 11 (4 ULg)Monthly oral ibandronate is well tolerated and efficacious in postmenopausal women: Results from the monthly oral pilot studyReginster, Jean-Yves ; ; et alin Journal of Clinical Endocrinology and Metabolism (2005), 90(9), 5018-5024 Context: Ibandronate, a potent, nitrogen-containing bisphosphonate developed for intermittent administration in postmenopausal osteoporosis, aims to overcome current adherence issues with daily and weekly ... [more ▼] Context: Ibandronate, a potent, nitrogen-containing bisphosphonate developed for intermittent administration in postmenopausal osteoporosis, aims to overcome current adherence issues with daily and weekly oral bisphosphonates through once-monthly oral dosing. Objective: The purpose of this study was to investigate the safety, pharmacodynamics, and pharmacokinetics of once-monthly oral ibandronate. Design: A randomized, 3-month, double-blind, placebo-controlled, phase I study (Monthly Oral Pilot Study) was conducted. Setting: The study was conducted at five clinical trial centers in the United Kingdom and Belgium. Patients or Other Participants: Subjects were postmenopausal women (age, 55 - 80 yr; >= 3 yr post menopause; n = 144). Intervention(s): Once-monthly oral ibandronate 50, 100, or 150 mg or placebo was used. After the first cycle, the 50-mg arm was split, with participants continuing on either 50 or 100 mg. Main Outcome Measure(s): Primary outcome measures were safety, serum and urinary C-telopeptide (CTX), and serum ibandronate AUC(0-infinity). Results: Once- monthly oral ibandronate was well tolerated, with a similar overall and upper gastrointestinal safety profile to placebo. Once- monthly ibandronate was also highly effective in decreasing bone turnover; substantial reductions from baseline in serum CTX (-56.7% and -40.7% in the 150- and 100- mg arms, respectively; P < 0.001 vs. placebo) and urinary CTX (-54.1% and -34.6%, respectively; P < 0.001 vs. placebo) were observed at d 91 (30 d after the final dose). Analysis of the area under the effect curve (d1 - 91) for change from baseline (percent x days) in serum CTX and urinary CTX indicated a dose- response relationship. The AUC(0-infinity) for ibandronate increased with dose but not in a dose- proportional manner. Conclusions: These findings indicate a potential role for once-monthly oral ibandronate in the treatment of postmenopausal osteoporosis. [less ▲] Detailed reference viewed: 14 (2 ULg)Once-monthly and daily oral ibandronate are at least as effective in improving proximal femur BMD in postmenopausal osteoporosis: 12-month data from MOBILEReginster, Jean-Yves ; ; et alin Annals of the Rheumatic Diseases (2005, June), 64(Suppl.III), 93 Detailed reference viewed: 2 (1 ULg)Two-year efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: the MOBILE study; ; et al in Annals of the Rheumatic Diseases (2005, June), 64(Suppl.III), 68 Detailed reference viewed: 10 (5 ULg) Monthly oral ibandronate is at least as effective as daily oral ibandronate: 1-year results from MOBILEReginster, Jean-Yves ; ; et alin Osteoporosis International (2005, March), 16(Suppl.3), 81-82 Detailed reference viewed: 4 (0 ULg)Once-monthly dosing of oral ibandronate is at least as effective as daily dosing in postmenopausal osteoporosis : 1-year results from mobileReginster, Jean-Yves ; ; et alin BONE (2005), 36(S2), 416 Detailed reference viewed: 3 (1 ULg)Novel ibandronate regimens in postmenopausal osteoporosis: design of the dosing intravenous administration (DIVA) study; Reginster, Jean-Yves ; et alin Osteoporosis International (2004, May), 15(Suppl.1), 118 Detailed reference viewed: 9 (0 ULg)Once-monthly oral ibandronate a new bisphosphonate dosing conceptReginster, Jean-Yves ; ; et alin Calcified Tissue International (2004), 74(S1), 85 Detailed reference viewed: 2 (2 ULg)Oral monthly ibandronate: rationale and clinical potential in postmenopausal osteoporosisReginster, Jean-Yves ; ; et alin Annals of the Rheumatic Diseases (2003, June) Detailed reference viewed: 23 (11 ULg)Prevention of early postmenopausal bone loss with oral tiludronate; DEROISY, Rita ; et alin Osteoporosis International (1996), 6(S1), 249 Detailed reference viewed: 22 (2 ULg) |
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