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Intermittent Cyclical Etidronate Treatment of Postmenopausal Osteoporosis

Watts, Nelson B., Harris, Steven T., Genant, Harry K., Wasnich, Richard D., Miller, Paul D., Jackson, Rebecca D., Licata, Angelo A., Ross, Philip, Woodson, Grattan C., Yanover, Melissa J., Mysiw, W.Jerry, Kohse, Larry, Rao, M. Bhaskar, Steiger, Peter, Richmond, Bradford, Chesnut, Charles H.·1990·New England Journal of Medicine

Abstract

BACKGROUND: To determine the effects of etidronate (a bisphosphonate that inhibits osteoclast-mediated bone resorption) in the treatment of postmenopausal osteoporosis, we conducted a prospective, two-year, double-blind, placebo-controlled, multicenter study in 429 women who had one to four vertebral compression fractures plus radiographic evidence of osteopenia. METHODS: The patients were randomly assigned to treatment with phosphate (1.0 g) or placebo twice daily on days 1 through 3, etidronate (400 mg) or placebo daily on days 4 through 17, and supplemental calcium (500 mg) daily on days 18 through 91 (group 1, placebo and placebo; group 2, phosphate and placebo; group 3, placebo and etidronate; and group 4, phosphate and etidronate). The treatment cycles were repeated eight times. The bone density of the spine was measured by dual-photon absorptiometry, and the rates of new vertebral fractures were determined from sequential radiographs. RESULTS: After two years, the patients receiving etidronate (groups 3 and 4) had significant increases in their mean (+/- SE) spinal bone density (4.2 +/- 0.8 percent and 5.2 +/- 0.7 percent, respectively; P less than 0.017). The rate of new vertebral fractures was reduced by half in the etidronate-treated patients (groups 3 and 4 combined) as compared with the patients who did not receive etidronate (groups 1 and 2 combined) (29.5 vs. 62.9 fractures per 1000 patient-years; P = 0.043); the effect of treatment was most striking in the subgroup of patients with the lowest spinal bone mineral density at base line, in whom fracture rates were reduced by two thirds (42.3 vs. 132.7 fractures per 1000 patient-years; P = 0.004). The addition of phosphate provided no apparent benefit. There were no significant adverse effects of treatment. CONCLUSIONS: Intermittent cyclical therapy with etidronate for two years significantly increases spinal bone mass and reduces the incidence of new vertebral fractures in women with postmenopausal osteoporosis.

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Authors
Watts, N. B., Harris, S. T., Genant, H. K., Wasnich, R. D., Miller, P. D., Jackson, R. D., Licata, A. A., Ross, P., Woodson, G. C., Yanover, M. J., Mysiw, W. J., Kohse, L., Rao, M. B., Steiger, P., Richmond, B., & Chesnut, C. H.
Venue
New England Journal of Medicine
Published
1990-07-12
Volume
323
Issue
2
Pages
73-79
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2336678594
Cited by
949
References
0
FWCI
82.13
Type
journal article
Language
en
Open access
closed

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