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

• Published in: Clinical therapeutics 2009-04, Vol.31 (4), p.751-761
• Main Authors: Emkey, Ronald, MD, Delmas, Pierre D., MD, PhD, Bolognese, Michael, MS, MD, Borges, Joao Lindolfo C., MD, CCD, Cosman, Felicia, MD, Ragi-Eis, Sergio, MD, Recknor, Christopher, MD, Zerbini, Cristiano A., MD, Neate, Colin, MSc, Sedarati, Farhad, PhD, Epstein, Solomon, MD, FRCP
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; alendronate; Alendronate - administration & dosage; Alendronate - adverse effects; Alendronate - therapeutic use; Biological and medical sciences; Bisphosphonates; Bone density; Bone Density - drug effects; Bone Density Conservation Agents - administration & dosage; Bone Density Conservation Agents - adverse effects; Bone Density Conservation Agents - therapeutic use; bone markers; bone mineral density; Collagen Type I - blood; Diphosphonates - administration & dosage; Diphosphonates - adverse effects; Diphosphonates - therapeutic use; Diseases of the osteoarticular system; Double-Blind Method; Drug Administration Schedule; Female; Fractures; Humans; ibandronate; Internal Medicine; Medical Education; Medical sciences; Middle Aged; Osteoporosis; Osteoporosis, Postmenopausal - drug therapy; Osteoporosis. Osteomalacia. Paget disease; Peptides - blood; Pharmacology. Drug treatments; postmenopausal osteoporosis; Treatment Outcome
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/j.clinthera.2009.04.018

Abstract Background: The MOTION (Monthly Oral Therapy with Ibandronate for Osteoporosis Intervention) study reported that once-monthly ibandronate was noninferior to once-weekly alendronate in terms of increasing bone mineral density (BMD) at the lumbar spine and total hip over 12 months. On analysis of secondary and exploratory end points in MOTION, which included trochanter and femoral neck BMD, monthly ibandronate was found to be noninferior to weekly alendronate. The coprimary, secondary, and exploratory BMD end points from MOTION have been previously reported. Objective: This report presents additional results from the MOTION study, including response rates in terms of lumbar spine and total hip BMD gains above baseline; findings from a comparison of serum concentrations of bone turnover markers; and tolerability analysis, including adverse events that led to withdrawal and gastrointestinal (GI) adverse events. Methods: MOTION was a 12-month (with 15-day follow-up), randomized, multinational, multicenter, double-blind, double-dummy, parallel-group, nonin-feriority study in postmenopausal women aged 55 to