Histomorphometric assessment of the long-term effects of alendronate on bone quality and remodeling in patients with osteoporosis

Journal of Clinical Investigation

Volumn 100, Issue 6, 1997, Pages 1475-1480

  Chavassieux, Pascale M ^a   Arlot, Monique E ^a   Reda, Celia ^b   Wei, Lynn ^b   Yates, A John ^b   Meunier, Pierre J ^a  

^a INSERM   (France)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Alendronate; Bisphosphonates; Bone remodeling; Histomorphometry; Postmenopausal osteoporosis

Indexed keywords

ALENDRONIC ACID;

ADULT; AGED; ARTICLE; BONE; BONE BIOPSY; BONE DENSITY; BONE MINERAL; BONE REMODELING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECT; DUAL ENERGY X RAY ABSORPTIOMETRY; FEMALE; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; MORPHOMETRICS; ORAL DRUG ADMINISTRATION; OSTEOPOROSIS; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

EID: 0030868816     PISSN: 00219738     EISSN: None     Source Type: Journal    
DOI: 10.1172/JCI119668     Document Type: Article

References (45)

1. Fleisch, H. 1991. Bisphosphonates: pharmacology and use in the treatment of tumour-induced hypercalcaemic and metastatic hone disease. Drugs. 42:919-944.
2. Fleisch, H. 1993. New Bisphosphonates in Osteoporosis. Osteoporosis Int. 3(Suppl. 2):515-522.
3. Rodan, G.A., J. G. Seedor, and R. Balena. 1993. Preclinical pharmacology of alendronate. Osteoporosis Int. (Suppl. 3):7-12.
4. Adami, S., M.C. Baroni, M. Broggini, L. Carratelli, I. Caruso, L. Gnessi, M. Laurenzi, A. Lombardi, G. Norhiato, S. Ortolani, et al. 1993. Treatment of postmenopausal osteoporosis with continuous daily oral alendronate in comparison with either placebo or intranasal salmon calcitonin. Osteoporosis Int. (Suppl 3):21-27.
5. Harris, S.T., B.J. Gertz, H.K. Genant, D.R. Eyeare, T.T. Survill, J.N. Ventura, J. DeBrock, E. Ricerca, and C.H. Chesnut III. 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.
6. Adami, S., M. Passeri, S. Orolani, M. Broggini, L. Carratelli, I. Caruso, G. Gandolini, L. Gnessi, M. Laurenzi, A. Lombardi, 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 (NY). 17:383-390.
7. Chesnut, C.H., M.R. McClung, K.E. Ensrud, N.H. Bell, H.K. Genant, S.T. Harris, F.R. Singer, J.L. Stock, R.A. Yood, P.D. Delmas, 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.
8. Adami, S., M. Mian, P. Gatti, M. Rossini, N. Zamberlan, F. Bertoldo, and V. Lo Cascio. 1994. Effects of two oral doses of alendronate in the treatment of Paget's disease of bone. Bone (NY). 15:415-417.
9. Liberman, U.A., S.R. Weiss, J. Bröll, H.W. Minne, H. Quan, N.H. Bell, J. Rodrigez-Portales, R.W. Downs, J. Dequeker, M. Favus, et al. 1995. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N. Engl. J. Med. 333(22):1437-1443.
10. Garnero, P., W.J. Shih, E. Gineyts, D.B. Karpf, and P.D. Delmas. 1994. Comparison of new biochemical markers of bone turnover in late postmenopausal osteoporotic women in response to alendronate treatment. J. Clin. Endocrinol. Metab. 79:1693-1700.
11. Devogelaer, J.P., H. Broll, R. Correa-Rotter, D.C. Comming, C. Nagant De Deuxchaisnes, P. Geusens, D. Hosking, P. Jaeger, J.M. Kaufman, M. Leite, et al. 1996. Oral alendronate induces progressive increases in hone mass of the spine, hip, and total body over 3 years in postmenopausal women with osteoporosis. Bone (NY). 18:141-150.
12. Tucci, J.R., R.P. Tonino, R.D. Emkey, C.A. Peverly, U. Kher, and A.C. Santora. 1996. Effect of three years of oral alendronate treatment in postmenopausal women with osteoporosis. Am. J. Med. 101:488-501.
13. Keshawarz, N.M., and R.R. Recker. 1984. Expansion of the medullary cavity at the expense of cortex in postmenopausal osteoporosis. Metab. Bone Dis. Relat. Res. 5:223-229.
14. Roux, J.P., M.E. Arlot, E. Gineyts, P.J. Meunier, and P.D. Delmas. 1995. Automatic interactive measurement of resorption cavities in transiliac bone biopsies and correlation with deoxypyridinoline. Bone (NY). 17:153-156.
15. Parfitt, A.M., M.K. Drezner, F. Glorieux, J.A. Kanis, H. Malluche, P.J. Meunier, S.M. Ott, and R.R. Recker. 1987. Bone histomorphometry: standardization of nomenclature, symbols, and units. J. Bone Miner. Res. 2:595-610.
16. Kragstrup, J., H.J.G. Gundersen, F. Melsen, and L. Mosekilde. 1982. Estimation of the three-dimensional wall thickness of completed remodeling sites in iliac trabecular bone. Metab. Bone Dis. Relat. Res. 4:113-119.
17. Chavassieux, P.M., M.E. Arlot, and P.J. Meunier. 1985. Intermethod variation in bone histomorphometry: comparison between manual and computerized methods applied to iliac bone biopsies. Bone (NY). 6:221-229.
18. Tukey, J.W., J.L. Ciminera, and J.F. Heyse. 1985. Testing the statistical certainty of a response to increasing doses of a drug. Biometrics. 41:295-301.
19. Capizzi, T., T.T. Survill, J.F. Heyse, and H. Malani. 1992. An empirical and simulated comparison of some tests for detecting progressiveness of response with increasing doses of a compound. Biom. J. 34:275-289.
20. Parfitt, A.M. 1990. Osteomalacia and related disorders. In Metabolic-Bone Disease and Related Disorders. L.V. Avioli and S.M. Krane, editors. W.B. Saunders Company, Philadelphia. 329-396.
21. Parfitt, A.M. 1983. The physiological and clinical significance of bone histomorphometric data. In Bone Histomorphometry: Techniques and Interpretations. R. Recker, editor. CRC Press, Inc., Boca Raton, FL. 143-223.
22. Siris, E., R.S. Weinstein, R. Altman, J.M. Conte, M. Favus, A. Lombardi, K. Lyles, H. McIlwain, W.A. Murphy, Jr., C. Reda, et al. 1996. Comparative study of alendronate versus etidronate for the treatment of Paget's disease of bone. J. Clin. Endocrinol. Metab. 81:961-967.
23. Reid, I.R., G.C. Nicholson, R.S. Weinstein, D.J. Hosking, T. Cundy, M.A. Kotowicz, W.A. Murphy, S. Yeap, S. Dufresne, A. Lombardi, et al. 1996. Biochemical and radiologie improvement in Paget's disease of bone treated with alendronate: a randomized placebo-controlled trial. Am. J. Med. 171:341-348.
24. Sietsema, W.K. F.H. Ebetino, A.M. Salvagno, and J.A. Bevan. 1989. Anti-resorptive dose-response relationships across three generations of bisphosphonates. Drugs Expl. Clin. Res. 15(9):389-396.
25. Hosking, D.J. 1990. Advances in the management of Paget's disease of bone. Drugs. 40:829-840.
26. Boyce, B.F., I. Fogelman, S. Ralston, L. Smith, E. Johnston, and I.T. Boyle. 1984. Focal osteomalacia due to low-dose disphosphonate therapy in Paget's disease. Lancet. i(8381):821-824.
27. Axelrod, D.W., and S.L. Teitelbaum. 1994. Results of long-term cyclical etidronate therapy: bone histomorphometry and clinical correlates. J. Bone Miner. Res. 9(Suppl.1):136.
28. Fleisch, H., and R.G.G. Russell. 1988. Bisphosphonates: a new class of drugs in diseases of bone and calcium metabolism. In Encyclopaedia (int) of Pharmacology and Therapeutics. P.P. Baker, editor. Springer-Verlag, Berlin. 83:441-166.
29. Fleisch, H. 1991. Bisphosphonates: pharmacology and use in the treatment of tumour-induced hypercalcaemic and metastatic bone disease. Drugs. 42:919-944.
30. Parfitt, A.M. 1980. Morphologic basis of bone mineral measurements: transient and steady-state effects of treatment in osteoporosis. Miner. Electrolyte Metab. 4:273-287.
31. Rossini, M., D. Gatti, N. Zamberlan, V. Braga, R. Dorizzi, and S. Adami. 1994. Long-term effects of a treatment course with oral alendronate of postmenopausal osteoporosis. J. Bone Miner. Res. 9:1833-1837.
32. Rosen, H.N., R. Dresner-Pollak, A.C. Moses, M. Rosenblatt, A.J. Zeind, J.D. Clemens, and S.L. Greenpan. 1994. Specificity of urinary excretion of cross linked N-telopeptides of type I collagen as markers of bone turnover in humans. Calcif. Tissue Int. 54:26-29.
33. Balena, R., A. Markatos, J.G. Seedor, M. Gentile, C. Stark, C.P. Peter, and G.A. Rodan. 1996. Long-term safety of the aminobisphosphonate alendronate in adult dogs. II Histomorphometric analysis of the L5 vertebrae. J. Pharmacol. Exp. Ther. 276:277-283.
34. Lafage, M.H., R. Balena, M.A. Battle, M. Shea, J.G. Seedor, H. Klein, W.C. Hayes, and G.A. Rodan. 1995. Comparison of alendronate and sodium fluoride effects on cancellous and cortical bone minipigs. J. Clin. Invest. 95: 2127-2133.
35. Balena, R., B.C. Toolan, M. Shea, A. Markatos, E.R. Myers, S.C. Lee, E.E. Opas, J.G. Seedor, H. Klein, D. Franenfield, 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.
36. Cummings, S.R., D.M. Black, M.C. Nevitt, W. Browner, J. Cauley, K. Enstrud, H.K. Genant, L. Palermo, J. Scott, and T.M. Vogt. 1993. Bone density at various sites for prediction of hip fractures. Lancet. 52:344-347.
37. Black, D.M., S.R. Cummings, and D. Thompson. 1996. The effect of alendronate on rates of vertebral and non-vertebral fractures in women with vertebral fractures: preliminary results of the fracture intervention trial. Osteoporosis Int. 6(Suppl.1):94.
38. Bone, H.G., R.W. Downs, Jr., J.R. Tucci., S.T. Harris, R.S. Weinstein, A.A. Licata., M.R. McClung, D.B. Kimmel, B.J. Gertz, E. Hale, and W.J. Polvino. 1997. Dose-response relationships for alendronate treatment in osteoporotic elderly women. J. Clin. Endocrinol. Metab. 82:265-274.
39. Parfitt, A.M., G.R. Mundy, G.R. Roodman, D.E. Hughes, and B.F. Boyce. 1996. A new model for the regulation of bone resorption, with particular reference to the effects of bisphosphonates. J. Bone Miner. Res. 11:150-159.
40. Sato, M., W. Grasser, N. Endo, R. Akins, H. Simmons, D.D. Thompson, E. Golub, and G.A. Rodan. 1991. Bisphosphonate action: alendronate localization in rat bone and effects on osteoclast ultrastructure. J. Clin. Invest. 88:2095-2105.
41. Sato, M., and W. Grasser. 1990. Effects of bisphosphonates on isolated rat osteoclasts as examined by reflected light microscopy. J. Bone Miner. Res. 5: 31-40.
42. Kanis, J.A., B.J. Gertz, F. Singer, and S. Ortolani. 1995. Rationale for the use of alendronate in osteoporosis. Osteoporosis Int. 5:1-13.
43. Hughes, D.E., S.P. Luckman, R. Graham, G. Russel, and M.J. Rogers. 1997. Involvement of the mevalonate pathway in osteoclast apoptosis and the mechanism of action of bisphosphonates. Bone (NY). 4(Suppl.):110S.
44. Cohen-Solal, M.E., M.S. Shih, M.W. Lundy, and A.E. Parfitt. 1991. A new method for measuring cancellous bone erosion depth: application to the cellular mechanisms of bone loss in postmenopausal osteoporosis. J. Bone Miner. Res. 6:1331-1337.
45. Eriksen, E.F., H.J.G. Gundersen, F. Melsen, and L. Mosekilde. 1984. Reconstruction of the formative site in trabecular bone in 20 normal individuals employing a kinetic model for matrix and mineral apposition. Metab. Bone Dis. Relat. Res. 5:243-252.