Efficacy and Safety of Monthly 150 mg Oral Ibandronate in Women with Postmenopausal Osteoporosis: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Background/Aims The aim of this study was to assess the efficacy and safety of monthly oral 150 mg ibandronate in women with postmenopausal osteoporosis (PMO). Methods A systematic review and meta-analysis were performed to determine treatment efficacy and safety outcomes between monthly oral 150 mg ibandronate and weekly 70 mg alendronate, daily 2.5 mg ibandronate, and a placebo. Results Eight randomized controlled trials were included in this systematic review and meta-analysis. Once-monthly 150 mg ibandronate therapy was clinically comparable to weekly 70 mg alendronate, showing increased bone mineral density (BMD) in both the lumbar spine and total hip. Pooled data from two cross-over trials showed that significantly more women with PMO preferred once-monthly ibandronate therapy to once-weekly alendronate therapy (relative risk [RR], 2.422; 95% confidence interval [CI], 2.111 to 2.825; p < 1 × 10-8) and found the monthly ibandronate regimen more convenient than the weekly alendronate regimen (RR, 3.096; 95% CI, 2.622 to 3.622; p < 1 × 10-8). Monthly 150 mg ibandronate therapy resulted in a significantly higher change in BMD of the lumbar spine than with the placebo. A once monthly 150 mg regimen produced greater increases in lumbar spine, total hip, femoral neck, and trochanter BMD than daily treatment, with a similar incidence of adverse events between the groups. Conclusions Once monthly 150 mg ibandronate therapy was clinically comparable to weekly 70 mg alendronate, and patients strongly preferred the convenience of monthly ibandronate over weekly alendronate. Monthly 150 mg ibandronate was superior to, and as well tolerated as, the daily treatment.

[1]  E. McCloskey,et al.  Update on monthly oral bisphosphonate therapy for the treatment of osteoporosis: focus on ibandronate 150 mg and risedronate 150 mg , 2009, Current medical research and opinion.

[2]  S. Adami,et al.  Once-monthly oral ibandronate in postmenopausal osteoporosis: translation and updated review. , 2009, Clinical therapeutics.

[3]  P. Delmas,et al.  Efficacy and tolerability of once-monthly oral ibandronate (150 mg) and once-weekly oral alendronate (70 mg): additional results from the Monthly Oral Therapy With Ibandronate For Osteoporosis Intervention (MOTION) study. , 2009, Clinical therapeutics.

[4]  R. Recker,et al.  Efficacy and safety of monthly oral ibandronate in the prevention of postmenopausal bone loss. , 2009, Bone.

[5]  P. Sambrook,et al.  Ibandronate dose response is associated with increases in bone mineral density and reductions in clinical fractures: results of a meta-analysis. , 2009, Bone.

[6]  E. Barrett-Connor,et al.  Treatment preference for monthly oral ibandronate and weekly oral alendronate in women with postmenopausal osteoporosis: A randomized, crossover study (BALTO II). , 2008, Joint, bone, spine : revue du rhumatisme.

[7]  J. Reginster,et al.  Monthly oral ibandronate is effective and well tolerated after 3 years: the MOBILE long-term extension , 2008, Clinical Rheumatology.

[8]  J. Reginster,et al.  Once-monthly oral ibandronate compared with weekly oral alendronate in postmenopausal osteoporosis: results from the head-to-head MOTION study , 2008, Current medical research and opinion.

[9]  P. Miller,et al.  Ibandronate and the risk of non-vertebral and clinical fractures in women with postmenopausal osteoporosis: results of a meta-analysis of phase III studies* , 2008, Current medical research and opinion.

[10]  O. Johnell,et al.  An estimate of the worldwide prevalence and disability associated with osteoporotic fractures , 2006, Osteoporosis International.

[11]  E. Brankin,et al.  Treatment persistence with once-monthly ibandronate and patient support vs. once-weekly alendronate: results from the PERSIST study , 2006, International journal of clinical practice.

[12]  C. Simonelli,et al.  Less frequent dosing of bisphosphonates in osteoporosis: focus on ibandronate , 2006, Current medical research and opinion.

[13]  Eunice Y Pyon Once-monthly ibandronate for postmenopausal osteoporosis: review of a new dosing regimen. , 2006, Clinical therapeutics.

[14]  C. Cooper,et al.  A new concept for bisphosphonate therapy: a rationale for the development of monthly oral dosing of ibandronate , 2006, Osteoporosis International.

[15]  M. Drezner,et al.  Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study , 2005, Annals of the rheumatic diseases.

[16]  K. Beusterien,et al.  Patient preference for once-monthly ibandronate versus once-weekly alendronate in a randomized, open-label, cross-over trial: the Boniva Alendronate Trial in Osteoporosis (BALTO) , 2005 .

[17]  J. Reginster,et al.  Monthly oral ibandronate is well tolerated and efficacious in postmenopausal women: results from the monthly oral pilot study. , 2005, The Journal of clinical endocrinology and metabolism.

[18]  J. Cramer,et al.  Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis* , 2005, Current medical research and opinion.

[19]  Dieter Felsenberg,et al.  Monthly Oral Ibandronate Therapy in Postmenopausal Osteoporosis: 1‐Year Results From the MOBILE Study , 2005, Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research.

[20]  F. Bauss,et al.  Ibandronate: A Clinical Pharmacological and Pharmacokinetic Update , 2004, Journal of clinical pharmacology.

[21]  G. Fuleihan,et al.  Patients with osteoporosis prefer once weekly to once daily dosing with alendronate. , 2004, Maturitas.

[22]  S. Emani,et al.  Compliance with pharmacologic therapy for osteoporosis , 2003, Osteoporosis International.

[23]  J. Mccombs,et al.  Compliance with drug therapies for the treatment and prevention of osteoporosis. , 2003, Maturitas.

[24]  S. Thompson,et al.  Quantifying heterogeneity in a meta‐analysis , 2002, Statistics in medicine.

[25]  A R Jadad,et al.  Assessing the quality of reports of randomized clinical trials: is blinding necessary? , 1996, Controlled clinical trials.

[26]  Harry K. Genant,et al.  Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. , 1993, The American journal of medicine.

[27]  H. Genant,et al.  Once-monthly oral ibandronate improves biomechanical determinants of bone strength in women with postmenopausal osteoporosis. , 2009, The Journal of clinical endocrinology and metabolism.

[28]  C. Perry,et al.  Ibandronate , 2012, Drugs.

[29]  G. Davey Smith,et al.  Meta-analyses of randomised controlled trials. , 1997, Lancet.