Abstract | OBJECTIVE: DESIGN: Double-blind, randomized, placebo-controlled clinical trial lasting 1 year. SETTING: Referral-based outpatient clinic. PATIENTS: Seventy-five postmenopausal women, 47 to 75 years of age, with one or more vertebral fractures due to osteoporosis. INTERVENTIONS: MEASUREMENTS: Bone turnover assessed by biochemical markers and iliac bone histomorphometry; bone loss assessed by serial measurement of bone density; and vertebral fracture rate. RESULTS: Compared with the placebo group, the median annual percentage change in bone mineral density in the estrogen group reflected increased or steady-state bone mineral density at the lumbar spine (5.3 compared with 0.2; P = 0.007), femoral trochanter (7.6 compared with 2.1; P = 0.03), and midradius (1.0 compared with -2.6, P less than 0.001) but showed no significant difference at the femoral neck (2.6 compared with 1.4; P = 0.17). Estrogen treatment uniformly decreased bone turnover as assessed by several methods including serum osteocalcin concentration (median change, -0.35 compared with 0.02 nmol/L; P less than 0.001). Histomorphometric evaluation of iliac biopsy samples confirmed the effect of estrogen on bone formation rate per bone volume (median change, -12.9 compared with -6.2% per year; P = 0.004). Also, 8 new fractures occurred in 7 women in the estrogen group, whereas 20 occurred in 12 women in the placebo group, yielding a lower vertebral fracture rate in the estrogen group (relative risk, 0.39; 95% CI, 0.16 to 0.95). CONCLUSIONS:
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Authors | E G Lufkin, H W Wahner, W M O'Fallon, S F Hodgson, M A Kotowicz, A W Lane, H L Judd, R H Caplan, B L Riggs |
Journal | Annals of internal medicine
(Ann Intern Med)
Vol. 117
Issue 1
Pg. 1-9
(Jul 01 1992)
ISSN: 0003-4819 [Print] United States |
PMID | 1534476
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Estrone
- Estradiol
- Medroxyprogesterone Acetate
- Medroxyprogesterone
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Topics |
- Administration, Cutaneous
- Administration, Oral
- Aged
- Bone Density
(drug effects)
- Double-Blind Method
- Drug Therapy, Combination
- Estradiol
(administration & dosage, adverse effects, blood)
- Estrone
(blood)
- Female
- Humans
- Medroxyprogesterone
(administration & dosage, analogs & derivatives)
- Medroxyprogesterone Acetate
- Middle Aged
- Osteoporosis, Postmenopausal
(complications, drug therapy)
- Prospective Studies
- Spinal Fractures
(etiology, prevention & control)
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