Journal article
Effects of ultralow-dose transdermal estradiol on bone mineral density: A randomized clinical trial
Obstetrics and gynecology (New York. 1953), Vol.104(3), pp.443-451
2004
DOI: 10.1097/01.AOG.0000137833.43248.79
PMID: 15339752
Abstract
OBJECTIVE: Because small increments in levels of endogenous plasma estradiol are associated with higher postmenopausal bone mineral density, we investigated the safety and effectiveness in preventing bone loss of unopposed, very-low-dose transdermal estradiol for postmenopausal women. METHODS: This was a randomized, placebo-controlled, double-blind trial with 2-year follow-up at 9 United States clinical centers. The study population comprised 417 postmenopausal women, aged 60-80 years, with intact uterus and bone mineral density z scores of -2.0 or higher, who were randomly assigned to receive either unopposed transdermal estradiol at 0.014 mg/d (n = 208) or placebo (n = 209). All participants received calcium and vitamin D supplementation. Lumbar spine and total hip bone mineral density change was measured by dual-energy X-ray absorptiometry; endometrial hyperplasia incidence was assessed by endometrial biopsy. RESULTS: Median plasma estradiol level in the estradiol group increased from 4.8 pg/mL at baseline to 8.5 pg/mL at 1 year (P < .001 versus baseline) and to 8.6 pg/mL at 2 years (P < .001 versus baseline) and was unchanged in the placebo group. Lumbar spine bone mineral density increased 2.6% in the estradiol group and 0.6% in the placebo group (between-group difference 2.0%, P < .001). Mean total hip bone mineral density increased 0.4% in the estradiol group and decreased 0.8% in the placebo group (between-group difference 1.2%, P < .001). Osteocaicin levels and bone-specific alkaline phosphatase were lower in the estradiol group than the placebo group (P < .001 each). Endometrial hyperplasia developed in 1 woman in the estradiol group but in none of the placebo group (difference in 2-year rates 0.5%, 95% confidence interval 0-7.3%). CONCLUSION: Postmenopausal treatment with low-dose, unopposed estradiol increased bone mineral density and decreased markers of bone turnover without causing endometrial hyperplasia. © 2004 by The American College of Obstetricians and Gynecologists.
Details
- Title: Subtitle
- Effects of ultralow-dose transdermal estradiol on bone mineral density: A randomized clinical trial
- Creators
- Bruce Ettinger - Kaiser PermanenteKristine E Ensrud - United States Department of Veterans AffairsRobert Wallace - University of California, San FranciscoKaren C Johnson - University of California, San FranciscoSteven R Cummings - University of California, San FranciscoVladimir Yankov - University of California, San FranciscoEric Vittinghoff - University of California, San FranciscoDeborah Grady - University of California, San Francisco
- Resource Type
- Journal article
- Publication Details
- Obstetrics and gynecology (New York. 1953), Vol.104(3), pp.443-451
- DOI
- 10.1097/01.AOG.0000137833.43248.79
- PMID
- 15339752
- NLM abbreviation
- Obstet Gynecol
- ISSN
- 0029-7844
- eISSN
- 1873-233X
- Publisher
- Elsevier Science
- Language
- English
- Date published
- 2004
- Academic Unit
- Epidemiology; Injury Prevention Research Center; Internal Medicine
- Record Identifier
- 9984363624702771
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