Risedronate prevents bone loss in early postmenopausal women: A prospective randomized, placebo-controlled trial

Climacteric

Volumn 8, Issue 3, 2005, Pages 251-262

  Hooper, M J ^a   Ebeling, P R ^b   Roberts, A P ^c   Graham, J J ^c   Nicholson, G C ^b   D'Emden, M ^d   Ernst, T F ^e   Wenderoth, D ^e  

^a UNIVERSITY OF SYDNEY   (Australia)

^b UNIVERSITY OF MELBOURNE   (Australia)

^c Ashford Cancer Centre   (Australia)

^d ROYAL BRISBANE AND WOMEN'S HOSPITAL   (Australia)

^e PROCTER AND GAMBLE PHARMACEUTICALS   (United States)

Author keywords

Bisphosphonates; Bone mineral density; Menopause; Osteoporosis; Risedronate

Indexed keywords

CALCIUM; PLACEBO; RISEDRONIC ACID;

ABDOMINAL PAIN; ADULT; ARTICLE; BONE DENSITY; BONE MASS; BONE MINERAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DUAL ENERGY X RAY ABSORPTIOMETRY; ESOPHAGUS ULCER; FEMALE; FEMUR NECK; GASTROINTESTINAL SYMPTOM; HUMAN; LUMBAR SPINE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; OSTEOLYSIS; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; VERTEBRA FRACTURE; VITAMIN SUPPLEMENTATION;

ADULT; AMINO ACIDS; BIOLOGICAL MARKERS; BONE DENSITY CONSERVATION AGENTS; CREATININE; DENSITOMETRY, X-RAY; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ETIDRONIC ACID; FEMALE; FEMUR; HUMANS; LUMBAR VERTEBRAE; MIDDLE AGED; OSTEOPOROSIS, POSTMENOPAUSAL; PROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 24044465846     PISSN: 13697137     EISSN: 14730804     Source Type: Journal    
DOI: 10.1080/13697130500118126     Document Type: Article

References (45)

1. Dempster DW, Shane E, Herbert W, Lindsay R. A simple method for correlative light and scanning electron microscopy of human iliac crest bone biopsies: qualitative observations in normal and osteoporotic subjects. J Bone Miner Res 1986;1:15-21
2. Ross PD, Davis JW, Epstein RS, Wasnich RD. Pre-existing fractures and bone mass predict vertebral fracture incidence in women. Ann Intern Med 1991;114:919-23
3. Melton LJ 3d, Atkinson EJ, O'Fallon WM, Wahner HW, Riggs BL. Long-term fracture prediction by bone mineral assessed at different skeletal sites. J Bone Miner Res 1993;8:1227-33
4. Cummings SR, Black DM, Nevitt MC, et al Bone density at various sites for prediction of hip fractures. Lancet 1993;341:72-5
5. Lindsay R, Silverman SL, Cooper C, et al. . Risk of new vertebral fracture in the year following a fracture. JAMA 2001;285:320-3
6. Jacobs S, Hillard TC. Hormone replacement therapy in the aged: a state of the art review. Drugs Aging 1996;3:193-213
7. Reid IR. Pharmacological management of osteoporosis in postmenopausal women: a comparative review. Drugs Aging 1999;15:349-63
8. Komulainen MH, Kroger H, Tuppurainen MT, et al. HRT and Vit D in prevention of non-vertebral fractures in postmenopausal women: a 5 year randomized trial. Maturitas 1998;31:45-54
9. Rossouw JE, Anderson GL, Prentice RL, et al. Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002;288:321-33
10. Shumaker SA, Legault C, Rapp SR, et al., for the WHIMS Investigators. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women. The Women's Health Initiative Memory Study: a randomized controlled trial. JAMA 2003;289:2651-62
11. Hays J, Ockene JK, Brunner RL, et al., Women's Health Initiative Investigators. Effects of estrogen plus progestin on health-related quality of life. N Engl J Med 2003;348:1839-54
12. Hulley S, Furberg C, Barrett-Connor E, et al., for the HERS Research Group. Noncardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/progestin Replacement Study follow-up (HERS II). JAMA 2002;288:58-66
13. Grady D, Herrington D, Bittner V, et al., for the HERS Research Group. Cardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/progestin Replacement Study follow-up (HERS II). JAMA 2002;288:49-57
14. Grady D. Postmenopausal hormones - therapy for symptoms only. N Engl J Med 2003;348:1835-7
15. Hahn RG. Compliance considerations with estrogen replacement: withdrawal bleeding and other factors. Am J Obstet Gynecol 1989;161:1854-8
16. Lufkin EG, Whitaker MD, Nickelsen T, et al. Treatment of established postmenopausal osteoporosis with raloxifene: a randomized trial. J Bone Miner Res 1998;13:1747-54
17. Delmas PD, Bjarnason NH, Mitlak BH, et al. Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med 1997;337:1641-7
18. Ettinger B, Black DM, Mitlak BH, et al., for the Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. JAMA 1999;282:637-45
19. Jolly EE, Bjarnason NH, Neven P, et al. Prevention of osteoporosis and uterine effects in postmenopausal women taking raloxifene for 5 years. Menopause 2003;10:337-44
20. Balfour JA, Goa KL. Raloxifene. Drugs Aging 1998;12:335-41
21. Davies GC, Huster WJ, Lu Y, Plouffe L Jr, Lakshmanan M. Adverse events reported by postmenopausal women in controlled trials with raloxifene. Obstet Gynecol 1999;93:558-65
22. Harris ST, Watts NB, Genant HK, et al., for the Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis. A randomized controlled trial. JAMA 1999;282:1344-52
23. Reginster J-Y, Minne HW, Sorensen OH, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Osteoporos Int 2000;11:83-91
24. Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC. Randomized trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet 1996;348:1535-41
25. Delmas PD, Balena R, Confravreux E, Hardouin C, Hardy P, Bremond A. Bisphosphonate rise-dronate prevents bone loss in women with artificial menopause due to chemotherapy of breast cancer: a double-blind, placebo-controlled study. J Clin Oncol 1997;15:955-62
26. Mortensen L, Charles P, Bekker PJ, DiGennaro J, Johnston CC Jr. Risedronate increases bone mass in an early postmenopausal population: two years of treatment plus one year of follow-up. J Clin Endocrinol Metab 1998;83:396-402
27. Hosking D, Chilvers CED, Christiansen C, et al. Prevention of bone loss with alendronate in postmenopausal women under 60 years of age. N Engl J Med 1998;338:485-92
28. Meunier PJ, Confavreux E, Tupinon I, Hardouin C, Delmas PD, Balena R. Prevention of early postmenopausal bone loss with cyclical etidronate therapy (a double-blind, placebo-controlled study and 1-year follow-up). J Clin Endocrinol Metab 1997;82:2784-91
29. Herd RJ, Balena R, Blake GM, Ryan PJ, Fogelman I. The prevention of early postmenopausal bone loss by cyclical etidronate therapy: a 2-year, double-blind, placebo-controlled study. Am J Med 1997;103:92-9
30. McClung M, Clemmesen B, Daifotis A, et al., for the Alendronate Osteoporosis Prevention Study Group. Alendronate prevents postmenopausal bone loss in women without osteoporosis. A double-blind, randomized, controlled trial. Ann Intern Med 1998;128:253-61
31. Wallach S, Cohen S, Reid DM, et al. Effects of risedronate treatment on bone density and vertebral fracture in patients on corticosteroid therapy. Calcif Tissue Int 2000;67:277-85
32. McClung MR, Geusens P, Miller PD, et al., for the Hip Intervention Program Study Group. Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 2001;344:333-40
33. Liberman UA, Weiss SR, Broll J, Minne HW, Quan H, Bell NH. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med 1995;333:1437-43
34. Colina RE, Smith M, Kikendall JW, Wong RK. A new probable increasing cause of esophageal ulceration: alendronate. Am J Gastroenterol 1997;92:704-6
35. de Groen PC, Lubbe DF, Hirsch LJ, et al. Esophagitis associated with the use of alendronate. N Engl J Med 1996;335:1016-21
36. Maconi G, Porro GB. Multiple ulcerative esophagitis caused by alendronate. Am J Gastroenterol 1995;90:1889-90
37. Faulkner KG, McClung MR. Quality control of DXA instruments in multicenter trials. Osteoporos Int 1995;5:218-27
38. Genant HK, Grampp S, Gluer CC, et al. Universal standardization for dual x-ray absorptiometry: patient and phantom cross-calibration results. J Bone Miner Res 1994;9:1503-14
39. Steiger P. Standardization of postero-anterior (PA) spine BMD measurements by DXA. Committee for Standards in DXA. Bone 1995;17:435
40. National Osteoporosis Foundation Working Group on Vertebral Fractures. Assessing vertebral fractures. J Bone Miner Res 1995;10:518-23
41. Armitage P. Tests for linear trends in proportions and frequencies. Biometrics 1955;11:375-86
42. Genant HK, Lucas J, Weiss S, et al., for the Estratab/Osteoporosis Study Group. Low-dose esterified estrogen therapy: effects on bone, plasma estradiol concentrations, endometrium, and lipid levels. Arch Intern Med 1997;157:2609-15
43. Liberman UA, Weiss SR, Broll J, et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med 1995;333:1437-43
44. Gallagher JC, Baylink DJ, Freeman R, McClung M. Prevention of bone loss with tibolone in postmenopausal women: results of two randomized, double-blind, placebo-controlled, dose-finding studies. J Clin Endocrinol Metab 2001;86:4717-26
45. Taggart H, Bolognese MA, Lindsay R, et al. Upper gastrointestinal tract safety of risedronate: a pooled analysis of 9 clinical trials. Mayo Clin Proc 2002;77:262-70