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Effect of Monitoring Bone Turnover Markers on Persistence with Risedronate Treatment of Postmenopausal Osteoporosis

Institut National de la Santé et de la Recherche Médicale (INSERM) Research Unit 831 and Université Claude Bernard Lyon 1 (P.D.D.), 69003 Lyon, France; AARDEX Ltd. (B.V.), CH-6302 Zug, Switzerland; Metabolic Bone Centre (R.E.), Northern General Hospital, South Yorkshire S5 7AU, United Kingdom; Department of Rheumatology (C.R.), Paris-Descartes University, Cochin Hospital, 75014 Paris, France; Division of Endocrinology (H.A.P.P.), Department of Internal Medicine, Erasmus MC, 3015 CE Rotterdam, The Netherlands; Klinikum Leverkusen (J.D.R.), 51375 Leverkusen, Germany; Procter & Gamble Pharmaceuticals (A.G.), Mason, Ohio 45040; Sanofi-Aventis (D.C.), Bridgewater, New Jersey 08807; and University of Cincinnati Bone Health and Osteoporosis Center (N.B.W.), Cincinnati, Ohio 45219

Address all correspondence and requests for reprints to: Pierre D. Delmas, M.D., Ph.D., Institut National de la Santé et de la Recherche Médicale Research Unit 403 and University Claude Bernard, Hôpital Edouard Herriot, Pavillon F, 69437 Lyon Cedex 03, France. E-mail: delmas{at}lyon.inserm.fr.

Context: Persistence with osteoporosis treatment is poor but is important for maximum benefit.

Objective: The objective of the study was to assess the impact of physician reinforcement using bone turnover markers (BTMs) on persistence with risedronate treatment.

Design and Setting: This was a 1-yr multinational prospective, open-label, blinded study in 171 osteoporosis centers in 21 countries.

Patients: A total of 2382 postmenopausal women (65–80 yr old) with spine/hip T-score –2.5 or less or T-score –1.0 or less with a low-trauma fracture.

Intervention: Intervention included calcium 500 mg/d, vitamin D 400 IU/d, and risedronate 5 mg/d for 1 yr. Centers were randomized to reinforcement (RE+) or no reinforcement (RE–). At 13 and 25 wk, reinforcement based on urinary N-telopeptide of type I collagen change from baseline was provided to the RE+ patients using the following response categories: good (>30% decrease), stable (–30% to +30% change), or poor (>30% increase).

Main Outcome Measures: Persistence assessed with electronic drug monitors was measured.

Results: In the overall efficacy population (n = 2302), persistence was unexpectedly high and was similar for both groups (RE–, 77%; RE+, 80%; P = 0.160). A significant relationship between the type of message and persistence was observed (P = 0.017). Compared with RE–, intervention based on a good BTM response was associated with a significant improvement in persistence [hazard ratio (HR) 0.71; 95% confidence interval (CI) 0.53–0.95]. Persistence was unchanged (HR 1.02; 95% CI 0.74–1.40) or lower (HR 2.22; 95% CI 1.27–3.89) when reinforcement was based on a stable or poor BTM response, respectively. Reinforcement was associated with a lower incidence of new radiologically determined vertebral fractures (odds ratio 0.4; 95% CI, 0.2–1.0).

Conclusions: Reinforcement using BTMs influences persistence with treatment in postmenopausal women with osteoporosis, depending on the BTM response observed.

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