Levonorgestrel and 17β-estradiol given transdermally for the prevention of postmenopausal osteoporosis
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- 作者：Warming ; L. ; Ravn ; P. ; Christiansen ; C.
- 关键词：Levonorgestrel ; 17β ; -Estradiol ; Osteoporosis
- 刊名：Maturitas
- 出版年：2005
- 出版时间：February 14, 2005
- 年：2005
- 卷：50
- 期：2
- 页码：78-85
- 全文大小：86.8 K
文摘
Aim: To evaluate the efficacy and safety of a new transdermal continuous combined hormone replacement therapy (HRT) for the prevention of postmenopausal osteoporosis. Methods: 212 osteopenic (lumbar spine and/or hip (femoral neck) bone mineral density (BMD) between −1.0 and −2.5 S.D. of the premenopausal mean value) postmenopausal women aged 45–65 years participated in a 2-year prospective study. Treatments were 45μg 17β-estradiol combined with 30 (n = 69) or 40μg (n = 72) levonorgestrel daily or placebo (n = 71) given as a 7-day patch. All received a daily supplement of 500mg calcium. BMD at lumbar spine (L2–L4), hip and total body, as well as blood and urinary biochemical markers of bone turnover (serum osteocalcin (sOC), serum bone-specific alkaline phosphatase (sBSAP), urinary calcium (uCa) and urinary CrossLaps (uCTX)) were measured regularly. Results: BMD at the lumbar spine, hip and total body increased by 8, 6 and 3 % (P < 0.001), respectively, in the hormone groups versus placebo. The bone markers all decreased accordingly (sOC: 37 % , sBSAP: 34 % and uCTX: 65 % from baseline (all P < 0.001)), except for uCa that did not change significantly. No significant dose-related effect of levonorgestrel was found. Vaginal bleeding/spotting decreased from 48 to 25 % of the HRT-treated women during the study period. Skin tolerance was good in 84 % of the women with no difference between the study groups. No incidences of endometrial hyperplasia, uterine or mammary cancer occurred. Conclusion: The transdermal combination of 17β-estradiol and levonorgestrel has a positive effect on BMD in an osteopenic postmenopausal population. Furthermore, a high safety profile was observed.