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.
- BMD, bone mineral density
- CI, confidence interval
- DXA, dual energy x ray absorptiometry
- GI, gastrointestinal
- ITT, intention to treat
- MOBILE, Monthly Oral iBandronate In LadiEs
- PP, per-protocol
- sCTX, C-telopeptide of the α-chain of type I collagen
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Published Online First 5 January 2006
Competing interests: The authors have received fees or reimbursement from the study sponsors, F Hoffmann-La Roche Ltd and GlaxoSmithKline, for the following activities/items: consulting: J-YR, SA, MG, SLS, CCh, MKD, CCo, DF, PDD, PDM; research grants: J-YR, MG, SLS, MKD, DF, PDM; attending symposia: J-YR, SA, JJS, MKD, CCo, DF, PDD; giving lectures: J-YR, SA, MG, SLS, MKD, RE, CCo, DF, PDD; funds for a member of staff: JJS; organising educational programmes: DF. LR, NM, BB are employees of Hoffmann-La Roche Ltd. PL has no competing interests.