Dose-response relationships for alendronate treatment in osteoporotic elderly women

Journal of Clinical Endocrinology and Metabolism

Volumn 82, Issue 1, 1997, Pages 265-274

  Bone, Henry G ^a   Downs Jr , Robert W ^b   Tucci, Joseph R ^c   Harris, Steven T ^d   Weinstein, Robert S ^e   Licata, Angelo A ^f   Mcclung, Michael R ^g   Kimmel, Donald B ^h   Gertz, Barry J ⁱ   Hale, Erika ⁱ   Polvino, William J ⁱ  

^a HENRY FORD HOSPITAL   (United States)

^b VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c ROGER WILLIAMS MEDICAL CENTER   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

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

^f LERNER RESEARCH INSTITUTE   (United States)

^g Osteoporosis Research Center   (United States)

^h CREIGHTON UNIVERSITY   (United States)

ⁱ MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALENDRONIC ACID; CALCIUM; CALCIUM CARBONATE;

ADULT; AGED; ARTICLE; BONE DENSITY; BONE MINERAL; BONE TURNOVER; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; HUMAN CELL; HUMAN TISSUE; MAJOR CLINICAL STUDY; MORPHOMETRICS; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; OSTEOPOROSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

AGED; AGED, 80 AND OVER; ALENDRONATE; BIOPSY; BONE AND BONES; BONE DENSITY; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; FRACTURES, BONE; HOMEOSTASIS; HUMANS; LUMBAR VERTEBRAE; MIDDLE AGED; MINERALS; OSTEOPOROSIS, POSTMENOPAUSAL; PROSPECTIVE STUDIES;

EID: 8044235628     PISSN: 0021972X     EISSN: None     Source Type: Journal    
DOI: 10.1210/jc.82.1.265     Document Type: Article

References (49)

1. Adami S, Passen, M, Ortolani S, et al. 1995 Effects of oral alendronate and intranasal salmon calcitonin on bone mass and biochemical markers of bone turnover in postmenopausal women with osteoporosis. Bone. 17:383-390.
2. Harris ST, Gertz BJ, Genant HK, et al. 1993 The effect of short term treatment with alendronate on vertebral density and biochemical markers of bone remodeling in early postmenopausal women. J Clin Endocrinol Metab. 76:1399-1406.
3. Chesnut CH, McClung MR, Ensrud KE, et al. 1995 Alendronate treatment of the postmenopausal osteoporotic woman: effect of multiple dosages on bone mass and bone remodeling. Am J Med. 99:144-152.
4. Eisman JA, Christiansen C, McClung M, et al. 1995 Alendronate prevents bone loss at the spine and hip in recently postmenopausal women. J Bone Miner Res. 10(Suppl 1):S176.
5. Liberman UA, Weiss, SR, Broll J, et al. 1995 Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med. 333:1437-1443.
6. Hanson DA, Weis MAE, Bollen AM, MasLan SL, Singer FR, Eyre DR. 1992 A specific immunoassay for monitoring human bone resorption: quantitation of type I collagen cross-linked N-telopeptides in urine. J Bone Miner Res. 7:1251-1257.
7. Eyre DR, Koob TJ, Van Ness KP. 1984 Quantitation of hydroxypyridinium crosslinks in collagen by high-performance liquid chromatography. Anal Biochem. 137:380-388.
8. Genant HK, Wu CY, van Kuijk C, Nevitt MC. 1993 Vertebral fracture assessment using a semi-quantitative technique. J Bone Miner Res. 8:1137-1148.
9. Baron R, Vignery A, Neff L, Silverglate A, Santa Maria A. 1983 Processing of undecalcified bone specimens for bone histomorphometry. In: Recker RR, ed. Bone histomorphometry: techniques and interpretation. Boca Raton: CRC Press; 13-35.
10. Recker RR, Kimmel DB, Parfitt AM, Davies KM, Keshawarz N, Hinders S. 1988 Static and tetracycline-based bone histomorphometric data from 34 normal post-menopausal females. J Bone Miner Res. 3:133-144.
11. Goldner J. 1938 A modification of the Masson trichrome technique for routine laboratory purposes. Am J Pathol. 14:237-243.
12. Villanueva AR, Czupinski G, Parfitt AM. 1979 A toluidine blue stain for calcification front, cement line, and osteoid seams on plastic-embedded undecalcified sections of bone. J Hist. 2:129.
13. Parfitt AM, Drezner MK, Glorieux FH, et al. 1987 Bone histomorphometry: standardization of nomenclature, symbols, and units. J Bone Miner Res. 2:595-609.
14. Tukey JW, Ciminera JL, Heyse JF. 1985 Testing the statistical certainty of a response to increasing doses of a drug. Biometrics. 41:295-301.
15. Kimmel DB, Recker RR, Gallagher JC, Vaswani AS, Aloia JF. 1990 A comparison of iliac bone histomorphometric data in post-menopausal osteoporotic and normal subjects. Bone Miner. 11:217-235.
16. Lufkin EG, Argueta R, Whitaker MD, et al. 1994 pamidronate: an unrecognized problem in gastrointestinal tolerability. Osteoporos Int. 4:320-322.
17. Consensus Development Conference. 1993 Diagnosis, Prophylaxis, and Treatment of Osteoporosis. Am J Med. 94:646-650.
18. Riggs BL, Melton III LJ. 1986 Involutional osteoporosis. N Engl J Med. 314:1676-1686.
19. Parfitt AM. 1993 Morphometry of bone resorption: introduction and overview [Review]. Bone. 14:435-441.
20. Eriksen EF. 1986 Normal and pathological remodeling of human trabecular bone: three dimensional reconstruction of the remodeling sequence in normals and in metabolic bone disease. Endocr Rev. 7:379-408.
21. Jones G, Nguyen T, Sambrook PN, Kelly PJ, Eisman JA. 1994 Progressive loss of bone in the femoral neck in elderly people: longitudinal findings from the Dubbo Osteoporosis Epidemiology Study. Br Med J. 309:691-695.
22. Parfitt AM. 1994 Age-related structural changes in trabecular, and cortical bone: cellular mechanisms and biochemical consequences [Review]. Calcif Tissue Int. 36(Suppl 1):S128.
23. Parfitt AM. 1992 Implications of architecture for the pathogenesis and prevention of vertebral fracture. Bone. 13(Suppl 2):S41-S47.
24. Parfitt AM. 1987 Trabecular bone architecture in the pathogenesis and prevention of fracture. Am J Med. 82:68-72.
25. Einhorn TA. 1992 Bone strength: the bottom line [Editorial]. Calcif Tissue Int. 51:333-339.
26. Frost HM. 1973 The origin and nature of transients in human bone remodeling dynamics. In: Frame B, Parfitt AM, Duncan H, eds. Clinical aspects of metabolic bone disease. Amsterdam: Excerpta Medica; 124-137.
27. Parfitt AM. 1980 Morphologic basis of bone mineral measurements: transient and steady state effects of treatment in osteoporosis. Miner Electrolyte Metab. 4:273-287.
28. Heaney RP. 1994 The bone-remodeling transient: implications for the interpretation of clinical studies of bone mass change. J Bone Miner Res. 9:1515-1519.
29. Fleisch H. 1991 Bisphosphonates. Pharmacology and use in the treatment of tumor-induced hypercalcemic and metastatic bone disease. Drugs. 42:919-944.
30. Flora L, Hassing GS, Cloyd GG, Bevan JA, Parfitt AM, Villanueva AR. 1981 The long-term skeletal effects of EHDP in dogs. Metab Bone Dis Rel Res. 3:289-300.
31. Axelrod, DW, Teitelbaum SL. 1994 Results of long-term cyclical etidronate therapy. Bone histomorphometry and clinical correlates. J Bone Miner Res. 9(Suppl 1):63.
32. Storm T, Thamsborg G, Steiniche T, Genant HK, Sorensen OH. 1990 Effect of intermittent cyclical etidronate therapy on bone mass and fracture rate in women with postmenopausal osteoporosis. N Engl J Med. 322:1265-1271.
33. Watts NB, Harris ST, Genant HK, et al. 1990 Intermittent cyclical etidronate treatment of postmenopausal osteoporosis. N Engl J Med. 323:73-79.
34. Harris ST, Watts NB, Jackson RD, et al. 1993 Four-year study of intermittent cyclic etidronate treatment of postmenopausal osteoporosis-three years of blinded therapy followed by one year of open therapy. Am J Med. 95:557-567.
35. Fleisch H. 1993 New bisphosphonates in osteoporosis. Osteoporos Int. 3(Suppl 2):S15-S22.
36. Rodan GA, Seedor JG, Balena R. 1993 Preclinical pharmacology of alendronate. Osteoporos Int. 3(Suppl 3):S7-S12.
37. Guy JA, Shea M, Peter CP, Morrissey R, Hayes WC. 1993 Continuous alendronate treatment throughout growth, maturation, and aging in the rat results in increases in bone mass and mechanical properties. Calcif Tissue Int. 53:283-288.
38. Toolan BC, Shea, M, Myers, ER, et al. 1992 Effects of 4-amino-1-hydroxybutylidene bisphosphate on bone biomechanics in rats. J Bone Miner Res. 7:1399-1406.
39. Balena R, Toolan BC, Shea M, et al. 1993 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. 92:2577-2586.
40. Hui SL, Slemenda CW, Johnston CC, Jr. 1989 Baseline measurement of bone mass predicts fractures in white women. Ann Intern Med. 111:355-361.
41. Ross PD, Davis JW, Epstein RS, Wasnich RD. 1991 Pre-existing fractures and bone mass predict vertebral fracture incidence in women. Ann Intern Med. 114:919-923.
42. Cummings S, Black DM, Nevitt MC, et al. 1993 Bone density at various sites for prediction of hip fractures. Lancet. 341:72-75.
43. Tucii JR, Tonino RP, Emkey RD, Peverly CA, Kher U, Santora II, AC, for the U.S. Alendronate Phase III Osteoporosis Treatment Study Group. 1996 Effect of Three Years of Oral Alendronate Treatment in Postmenopausal Women with Osteoporosis. Am J Med. Vol. 101, No. 5: 488-501.
44. Gertz BJ, Holland SD, Kline WF, et al. 1995 Studies of the oral bioavailability of alendronate. Clin Pharmacol Ther. 58:288-298.
45. Lindsay R, Cosman F, Nieves J, Dempster DW, Shen V. 1993 A controlled clinical trial of the effects of 1-34 hPTH in estrogen treated osteoporotic women. J Bone Miner Res. 8(Suppl 1):S130.
46. Greenspan SL, Holland S, Maitland-Ramsey L, et al. 1996 Nocturnal stimulation of parathyroid hormone: a mechanism to explain the continued improvement in bone and mineral density following alendronate therapy. Proc Assoc Am Physicians. 108:230-238.
47. Dawson-Hughes B. 1991 Calcium supplementation and bone loss: a review of controlled clinical trials. Am J Clin Nutr. 54:274S-280S.
48. Reid IR, Ames RW, Evans MC, Gamble GD, Sharpe SJ. 1995 Long-term effects of calcium supplementation on bone loss and fractures in postmenopausal women: a randomized controlled trial. Am J Med. 98:331-335.
49. Dawson-Hughes B, Dallai GE, Krall EA, Sadowski L, Sahyoun N, Tannenbaum S. 1990 A controlled trial of the effect of calcium supplementation on bone density in postmenopausal women. N Engl J Med. 323:878-883.