Matrix delivery transdermal 17 beta-estradiol for the prevention of bone loss in postmenopausal women

A total of 277 early postmenopausal women were enrolled in this placebo-con trolled 2-year study to examine the efficacy of a matrix transdermal 17 bet a-estradiol system, at three different dosages (25, 50 and 75 mu g/day) com bined with sequential oral dydrogester-one 20 mg/day, in preventing bone lo ss. At 2 years, the difference from placebo in percentage change from basel ine of L1-4 lumbar spine bone mineral density (BMD) (assessed by dual-energ y X-ray absorptiometry) was 4.7% +/- 0.7% with estradiol 25 mu g/day, 7.3% +/- 0.7% with estradiol 50 mu g/day and 8.7% +/- 0.7% with estradiol 75 mu g/day (all values mean +/- SEM), There were also significant increases in f emoral neck, trochanter and total hip BMD with all doses of estradiol compa red with placebo. Additionally, most patients had a significant gain (incre ase greater than 2.08%) in lumbar spine bone mass compared with placebo. Pa tients who received estradiol also experienced clinically significant and d ose-related decreases in total serum osteocalcin, serum bone alkaline phosp hatase and urinary C-telopeptide, with all three markers of bone turnover r eturning to premenopausal levels. Estradiol was well tolerated during the 2 -year treatment period, Transdermal estradiol is effective and well tolerat ed at dosages between 25-75 mu g/day in the prevention of bone loss in post menopausal women; 25 mu g/day offers an effective option for those women wh o cannot tolerate higher doses.