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Treatment of postmenopausal osteoporosis with transdermal estrogen.

AbstractOBJECTIVE:
To evaluate the tolerance and effectiveness of transdermal estrogen for women with established postmenopausal osteoporosis and vertebral fractures.
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:
Thirty-nine women received dermal patches delivering 0.1 mg of 17 beta-estradiol for days 1 to 21 and oral medroxyprogesterone acetate for days 11 to 21 of a 28-day cycle. Another 39 women received placebo.
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:
Transdermal estradiol treatment is effective in postmenopausal women with established osteoporosis.
AuthorsE 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
JournalAnnals of internal medicine (Ann Intern Med) Vol. 117 Issue 1 Pg. 1-9 (Jul 01 1992) ISSN: 0003-4819 [Print] United States
PMID1534476 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Estrone
  • Estradiol
  • Medroxyprogesterone Acetate
  • Medroxyprogesterone
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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