Alendronate prevents postmenopausal bone loss in women without osteoporosis - A double-blind, randomized, controlled trial

Annals of Internal Medicine

Volumn 128, Issue 4, 1998, Pages 253-261

  McClung, Michael ^a   Clemmesen, Bjørg ^b   Daifotis, Anastasia ^c   Gilchrist, Nigel L ^d   Eisman, John ^e   Weinstein, Robert S ^f   El Hajj Fuleihan, Ghada ^g   Reda, Celia ^c   Yates, A John ^c   Ravn, Pernille ^b  

^a EARLE A CHILES RESEARCH INSTITUTE   (United States)

^b CENTER FOR CLINICAL AND BASIC RESEARCH   (Denmark)

^c MERCK RESEARCH LABORATORIES   (United States)

^d PRINCESS MARGARET HOSPITAL   (New Zealand)

^e ST VINCENT S HOSPITAL   (Australia)

^f UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

^g BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALENDRONIC ACID;

AGING; ARTICLE; BONE ATROPHY; BONE DENSITY; BONE MINERAL; BONE TURNOVER; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MORPHOMETRICS; ORAL DRUG ADMINISTRATION; OSTEOLYSIS; OSTEOPOROSIS; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

EID: 6844266291     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-128-4-199802150-00001     Document Type: Article

References (37)

1. Riggs BL, Melton LJ 3d. The prevention and treatment of osteoporosis. N Engl J Med. 1992;327:620-7.
2. Cooper C, Campion C, Melton LJ 3d. Hip fractures in the elderly: a world-wide projection. Osteoporosis Int. 1992;2:285-9.
3. Melton LJ 3d, Chrischilles EA, Cooper C, Lane AW, Riggs BL. Perspective. How many women have osteoporosis? J Bone Miner Res. 1992;7:1005-10.
4. Boyce WJ, Vessey MP. Rising incidence of fracture of the proximal femur. Lancet. 1985;1:150-1.
5. Nguyen T, Sambrook P, Kelly P, Jones G, Lord S, Freund J, et al. Prediction of osteoporotic fractures by postural instability and bone density. BMJ. 1993;307:1111-5.
6. Cummings SR, Black DM, Nevitt MC, Browner W, Cauley J, Ensrud K, et al. Bone density at various sites for prediction of hip fractures. The Study of Osteoporotic Fractures Research Group. Lancet. 1993;341:72-5.
7. Jones G, Nguyen T, Sambrook P, Kelly PJ, Eisman JA. Progressive loss of bone in the femoral neck in elderly people: longitudinal findings from the Dubbo osteoporosis epidemiology study. BMJ. 1994;309:691-5.
8. Ensrud KE, Palermo L, Black DM, Cauley J, Jergas M, Orwoll ES, et al. Hip and calcaneal bone loss increase with advancing age: longitudinal results from the study of osteoporotic fractures. J Bone Miner Res. 1995;10:1778-87.
9. Liberman UA, Weiss SR, Broll J, Minne HW, Quan H, Bell NH, et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal women. The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med. 1995;333:1437-43.
10. Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, et al. Randomized trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet. 1996;348:1535-41.
11. Cauley JA, Seeley DG, Ensrud K, Ettinger B, Black D, Cummings SR. Estrogen replacement therapy and fractures in older women. Study of Osteoporotic Fractures Research Group. Ann Intern Med. 1995;122:9-16.
12. Harris RB, Laws A, Reddy VM, King A, Haskell WL. Are women using postmenopausal estrogens? A community survey. Am J Public Health. 1990; 80:1266-8.
13. Ryan PJ, Harrison R, Blake GM, Fogelman I. Compliance with hormone replacement therapy (HRT) after screening for postmenopausal osteoporosis. Br J Obstet Gynaecol. 1992;99:325-8.
14. Colditz GA, Hankinson SE, Hunter DJ, Willett WC, Manson JE, Stampfer MJ, et al. The use of estrogens and progestins and the risk of breast cancer in postmenopausal women. N Engl J Med. 1995;332:1589-93.
15. Dupont WD, Page DL. Menopausal estrogen replacement therapy and breast cancer. Arch Intern Med. 1992;151:67-72.
16. Balena R, Toolan BC, Shea M, Markatos A, Myers ER, Lee SC, et al. The effects of 2-year treatment with the aminobisphosphonate alendronate on bone metabolism, bone histomorphometry, and bone strength in ovariectomized nonhuman primates. J Clin Invest. 1993;92:2577-86.
17. Reginster JY, Albert A, Lecart MP, Lambelin P, Denis D, Deroisy R, et al. 1-year controlled randomised trial of prevention of early postmenopausal bone loss by prevention of intranasal calcitonin. Lancet. 1987;2:1481-3.
18. Faulkner KG, McClung MR. Quality control of DXA instruments in multicenter trials. Osteoporosis Int. 1995;5:218-27.
19. Reid IR, Nicholson GC, Weinstein RS, Hosking DJ, Cundy T, Kotowics MA, et al. Biochemical and radiologic improvement in Paget's disease of bone treated with alendronate: a randomized, placebo-controlled trial. Am J Med. 1996;101:339-40.
20. Tukey JW, Ciminera JL, Heyse JF. Testing the statistical certainty of a response to increasing doses of drugs. Biometrics. 1985;41:295-301.
21. Capizzi T, Survill TT, Heyse JF, Malani H. An empirical and simulated comparison of some tests for detecting progressiveness of response with increasing doses of a compound. Biometrical Journal. 1992;34:275-89.
22. Elders PJ, Netelenbos JC, Lips P, van Ginkel FC, van der Stelt PF. Accelerated vertebral bone loss in relation to the menopause: a cross-sectional study on lumbar bone density in 286 women of 45 to 55 years of age. Bone Mineral. 1988;5:11-9.
23. Hansen MA, Overgaard K, Christiansen C. Spontaneous postmenopausal bone loss in different skeletal areas - followed up for 15 years. J Bone Miner Res. 1995;10:205-10.
24. Assessment of fracture risk and its implications to screening for postmenopausal osteoporosis. WHO Technical Report Series #843. Geneva: World Health Organization; 1994.
25. Prince RL, Smith M, Dick IM, Price RI, Webb PG, Henderson NK, et al. Prevention of postmenopausal osteoporosis. A comparative study of exercise, calcium supplementation, and hormone-replacement therapy. N Engl J Med. 1991;325:1189-95.
26. Reid IR, Ames RW, Evans MC, Gamble GD, Sharpe SJ. Effects of calcium supplementation on bone loss in postmenopausal women. N Engl J Med. 1993;328:460-4.
27. Aloia JF, Vaswani A, Yeh JK, Ross PL, Flaster E, Dilmanian FA. Calcium supplementation with and without hormone replacement therapy to prevent postmenopausal bone loss. Ann Intern Med. 1994;120:97-103.
28. Effects of hormone therapy on bone mineral density: results from the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. The Writing Group for the PEPI Trial. JAMA. 1996;276:1389-96.
29. Speroff L, Rowan J, Symons J, Genant H, Wilborn W. The comparative effects on bone density, endometrium, and lipids of continuous hormones as replacement therapy (CHART study). A randomized controlled trial. JAMA. 1996;276:1397-403.
30. Field CS, Ory SJ, Wahner HW, Herrmann RR, Judd HL, Riggs BL. Preventive effects of transdermal 17 β-estradiol on osteoporotic changes after surgical menopause: a two-year placebo-controlled trial. Am J Obstet Gynecol. 1993;168:114-21.
31. Reginster JY, Deroisy R, Denis D, Collette J, Lecart MP, Sarlet N, et al. Prevention of postmenopausal bone loss by tiludronate. Lancet. 1989;2:1469-71.
32. Raisz LG, Wiita B, Artis A, Bowen A, Schwartz S, Trahiotis M, et al. Comparison of the effects of estrogen alone and estrogen plus androgen on biochemical markers of bone formation and resorption in postmenopausal women. J Clin Endocrinol Metab. 1996;81:37-43.
33. Chesnut CH 3d, Bell NH, Clark GS, Drinkwater BL, English SC, Johnston CC Jr, et al. Hormone replacement therapy in postmenopausal women: urinary N-telopeptide of type I collagen monitors therapeutic effect and predicts response of bone mineral density. Am J Med. 1997;102:29-37.
34. Masarachia P, Weinreb M, Balena R, Rodan GA. Comparison of the distribution of 3H-alendronate and 3H-etidronate in rat and mouse bones. Bone. 1996;19:281-90.
35. Siris E, Weinstein RS, Altman JM, Conte JM, Favus M, Lombardi A, et al. Comparative study of alendronate versus etidronate for the treatment of Paget's disease of bone. J Clin Endocrinol Metab. 1996;81:961-7.
36. Arlot MC, Meunier PJ, Chavassieux P, Recker R, Reda C, Wei L, et al. Effects of long-term alendronate treatment for postmenopausal osteoporosis on bone histomorphometry [Abstract]. J Bone Miner Res. 1995;10(Suppl 1):S199.
37. de Groen PC, Lubbe DF, Hirsch LJ, Daifotis A, Stephenson W, Freedholm D, et al. Esophagitis associated with the use of alendronate. N Engl J Med. 1996;335:1016-21.