Mr Barton is an employee of Procter & Gamble. Dr Felsenberg serves as a consultant for Eli Lilly and Company, GlaxoSmithKline, Merck & Co., Novartis, Nycomed, Procter & Gamble, Roche, and Schering. Dr Watts received honoraria from Aventis, Merck & Co., and Procter & Gamble, serves as a consultant for Aventis, Eli Lilly and Company, GlaxoSmithKline, Merck & Co., Novartis, NPS Pharmaceuticals, Procter & Gamble, Roche, Servier, and Wyeth, and receives funding through his university from Amgen, Aventis, Eli Lilly and Company, Merck & Co., Novartis, and Procter & Gamble. All other authors have no conflict of interest.
Relationship Between Changes in BMD and Nonvertebral Fracture Incidence Associated With Risedronate: Reduction in Risk of Nonvertebral Fracture Is Not Related to Change in BMD†
Version of Record online: 8 AUG 2005
Copyright © 2005 ASBMR
Journal of Bone and Mineral Research
Volume 20, Issue 12, pages 2097–2104, December 2005
How to Cite
Watts, N. B., Geusens, P., Barton, I. P. and Felsenberg, D. (2005), Relationship Between Changes in BMD and Nonvertebral Fracture Incidence Associated With Risedronate: Reduction in Risk of Nonvertebral Fracture Is Not Related to Change in BMD. J Bone Miner Res, 20: 2097–2104. doi: 10.1359/JBMR.050814
- Issue online: 4 DEC 2009
- Version of Record online: 8 AUG 2005
- Manuscript Accepted: 4 AUG 2005
- Manuscript Revised: 25 JUL 2005
- Manuscript Received: 15 FEB 2005
- 1NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis and Therapy 2001 Osteoporosis prevention, diagnosis, and therapy. JAMA 285: 785–795.
- 22005 America's Bone Health: The state of osteoporosis and low bone mass. Available at http://www.nof.org/advocacy/prevalence/. Accessed July 18, 2005.
- 31992 Perspective. How many women have osteoporosis? J Bone Miner Res 7: 1005–1010., , , ,
- 4Food and Drug Administration 2005 Guidelines for preclinical and clinical evaluation of agents used in the prevention or treatment of postmenopausal osteoporosis. Available at http://www.fda.gov/cder/guidance/osteo.pdf. Accessed July 18, 2005.
- 52002 Treatment of postmenopausal osteoporosis. Lancet 359: 2018–2026.
- 62002 Uncertain future of trials in osteoporosis. Osteoporos Int 13: 443–449., , , , , , ,
- 72003 Surrogates for fracture endpoints in clinical trials. J Bone Miner Res 18: 1146–1149.
- 82002 Summary of meta-analyses of therapies for postmenopausal osteoporosis and the relationship between bone density and fractures. Endocrinol Metab Clin North Am 31: 659–679., , , , , ,
- 9Thompson D for the Fracture Intervention Trial Research Group 1999 Larger increases in bone mineral density during alendronate therapy are associated with a lower risk of new vertebral fractures in women with postmenopausal osteoporosis. Arthritis Rheum 42: 1246–1254., , , , , , , ,
- 102004 Statistical validation of surrogate endpoints: Is bone density a valid surrogate for fracture. J Musculoskel Neuron Interact 4: 64–74., ,
- 112004 The relationship between changes in bone mineral density and fracture risk reduction with anti-resorptive drugs: Some issues with meta-analyses. J Bone Miner Res 19: 330–337., ,
- 122004 Changes in bone mineral density explain little of the reduction in vertebral or nonvertebral fracture risk with anti-resorptive therapy. Bone 34: 599–604.,
- 132000 Antifracture efficacy of antiresorptive agents are related to changes in bone density. J Clin Endocrinol Metab 85: 231–236.,
- 142002 Improvement in spine bone density and reduction in risk of vertebral fractures during treatment with antiresorptive drugs. Am J Med 112: 281–289., , , , , ,
- 152003 Changes in bone mineral density as a predictor of vertebral fracture efficacy with ibandronate: Results from a phase III fracture study. J Bone Miner Res 18 S2: S160., , , , ,
- 162002 Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy. J Bone Miner Res 17: 1–10., , , , ,
- 172004 The relationship between changes in bone mineral density and vertebral fracture risk associated with risedronate: Greater increases in bone mineral density do not relate to greater decreases in fracture risk. J Clin Densitom 7: 255–261., , , , , , ,
- 182004 Relationship between changes in biochemical markers of bone turnover and BMD to predict vertebral fracture risk. J Bone Miner Res 19: 394–401., , , , ,
- 19for the Fracture Intervention Trial Study Group 2004 Change in bone turnover and hip, non-spine, and vertebral fracture in alendronate-treated women: The fracture intervention trial. J Bone Miner Res 19: 1250–1258., , , , , , , , ,
- 201999 The Evaluation of Osteoporosis: Dual Energy X-Ray Absorptionmetry and Ultrasound in Clinical Practice, 2nd ed. Martin Dunitz Ltd, London, UK., ,
- 212002 Changes in bone density and turnover explain the reductions in incidence of nonvertebral fractures that occur during treatment with antiresorptive agents. J Clin Endocrinol Metab 87: 1586–1592., , , , ,
- 222004 The relationship between osteoporotic fracture risk and a surrogate: Apparent discrepancies between analyses based on individual patient data and summary statistics. Pharm Stat 3: 205–212.
- 232003 Exploring the relationship between surrogates and clinical outcomes: Analysis of individual patient data vs. meta-regression on group-level summary statistics. J Biopharm Stat 13: 777–792.,
- 24Miller PD for the Vertebral Efficacy With Risedronate Therapy Study Group (VERT) 1999 Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis. A randomized controlled trial. JAMA 282: 1344–1352., , , , , , , , , , ,
- 25Eastell R on behalf of the Vertebral Efficacy With Risedronate Therapy Study Group (VERT) 2000 Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Osteoporos Int 11: 83–91., , , , , , , , , ,
- 26Reginster JY for the Hip Intervention Program Study Group 2001 Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 344: 333–340., , , , , , , , , , ,
- 272001 A method to assess the proportion of treatment effect explained by a surrogate endpoint. Stat Med 20: 3175–3188., ,
- 281992 Statistical validation of intermediate endpoints for chronic diseases. Stat Med 11: 167–178., ,
- 291998 Updated data on proximal femur bone mineral levels of US adults. Osteoporos Int 8: 468–489., , , , , , ,
- 302004 Letter to the editor. Bone 35: 1222–1224., , , ,
- 312004 Response to letter to the editor. Bone 35: 1225–1226.,
- 322003 Proportion of treatment effect (PTE) explained by a surrogate marker. Stat Med 22: 3449–3459., ,
- 332005 Treating individuals 4: Can meta-analysis help target interventions at individuals most likely to benefit? Lancet 365: 341–346.,
- 341999 Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: Results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA 282: 637–645., , , , , , , , , , , , , , , , ,
- 352004 Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 19: 1241–1249., , , , , , , , , ,
- 361996 Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 348: 1535–1541., , , , , , , , , , , , , ,
- 371998 Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: Results from the Fracture Intervention Trial. JAMA 280: 2077–2082., , , , , , , , , , , , ,
- 382000 Fracture Intervention Trial. Fracture risk reduction with alendronate in women with osteoporosis: The Fracture Intervention Trial. FIT Research Group. J Clin Endocrinol Metab 85: 4118–4124., , , , , , , ,
- 392001 Six and twelve month changes in bone turnover are related to reduction in vertebral fracture risk during 3 years of raloxifene treatment in postmenopausal osteoporosis. Osteoporos Int 12: 922–930., , , , ,
- 402003 Relationship of early changes in bone resorption to the reduction in fracture risk with risedronate. J Bone Miner Res 18: 1051–1056., , , , ,
- 412004 Risedronate preserves bone architecture in postmenopausal women with osteoporosis as measured by three-dimensional microcomputed tomography. Bone 34: 736–746., , , , ,
- 422005 Femoral neck trabecular microstructure in ovariectomized ewes treated with calcitonin: MRI microscopic evaluation. J Bone Miner Res 20: 125–130., , , , , , , , , , ,