Short term effects of SHD 386L and levonorgestrel on bone and mineral metabolism in the postmenopause: a double-blind randomised placebo-controlled trial.

Abstract:

:Forty-five healthy postmenopausal women participated in a study designed to examine the effects on bone and mineral metabolism of SHD 386L, a new hormone replacement therapy (HRT) regime. This oral preparation delivers 2 mg estradiol valerate daily and 75 micrograms of levonorgestrel from days 17-28 inclusive of a 28-day cycle. The study was double-blind, randomized and placebo controlled. Patients who received SHD 386L exhibited significant falls in plasma calcium, ionised calcium, phosphate and total alkaline phosphatase. No alteration, however, was observed in plasma osteocalcin. No significant changes in mineral metabolism were observed in a parallel group receiving levonorgestrel alone. The results indicate that SHD 386L is likely to be protective to the skeleton through inhibition of bone resorption and that such actions are attributable to the estrogen component. The preparation was well tolerated, compliance was satisfactory and serious adverse affects were not seen. The above biochemical evidence for skeletal protection will require to be supplemented by prospective biophysical evidence of the effect of SHD 386L on bone mineral density.

journal_name

Maturitas

journal_title

Maturitas

authors

Purdie DW,Hay AW,Everett M

doi

10.1016/0378-5122(92)90114-j

keywords:

subject

Has Abstract

pub_date

1992-03-01 00:00:00

pages

189-99

issue

3

eissn

0378-5122

issn

1873-4111

pii

0378-5122(92)90114-J

journal_volume

14

pub_type

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