Abstract
The effects of 7 years of risedronate treatment were evaluated in a second 2-year extension of a 3-year vertebral fracture study in women with osteoporosis. For the first 5 years of the study, women received risedronate 5 mg/day or placebo according to the original randomization, with maintenance of blinding. All the women who entered into the 6–7 years extension study received risedronate 5 mg/day. Endpoints included vertebral and nonvertebral fracture assessments, changes in biochemical markers of bone turnover, and bone mineral density (BMD) measurements. A total of 164 women (placebo/risedronate group, 81; risedronate group, 83) entered the 6–7 years extension study and 136 (83%) completed the study. Annualized incidence of new vertebral fractures during the 6–7 years was similar between the 2 treatment groups (3.8%). The incidence of vertebral fractures did not change in the 7-year risedronate group during the 6–7 years as compared to 4–5 years, while a significant reduction was observed in the placebo group that switched to risedronate treatment during years 6–7. The incidence of nonvertebral fractures was 7.4% and 6.0% in the placebo/risedronate and risedronate groups, respectively, during years 6–7. Urinary N-telopeptide decreased from baseline by 54% and 63% at 3 months and 7 years, respectively, in the risedronate group. The increases in BMD from baseline after 5 years of risedronate treatment were maintained or increased further during years 6–7; lumbar spine BMD after 5 and 7 years of risedronate treatment increased from baseline by 8.8% and 11.5%, respectively, for this extension study population. Risedronate was well tolerated and the occurrence of upper gastrointestinal adverse events was low. After 7 years of continuous risedronate treatment there were significant increases in BMD and decreases in bone turnover to within premenopausal levels and there was no indication of any loss of anti-fracture efficacy.
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Acknowledgments
The authors wish to thank Elaine Taylor for her assistance in the writing and editing of the manuscript and Joanna Tench for her assistance in the preparation of the manuscript. This study was sponsored by The Alliance for Better Bone Health (Procter & Gamble Pharmaceuticals, Inc, Cincinnati, Ohio, and Aventis Pharmaceuticals, Inc, Bridgewater, New Jersey).
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Mellström, D.D., Sörensen, O.H., Goemaere, S. et al. Seven Years of Treatment with Risedronate in Women with Postmenopausal Osteoporosis. Calcif Tissue Int 75, 462–468 (2004). https://doi.org/10.1007/s00223-004-0286-7
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DOI: https://doi.org/10.1007/s00223-004-0286-7