Low doses of estradiol in combination with gestodene to prevent early postmenopausal bone loss

OBJECTIVE: Our purpose was to study combinations of estradiol and gestodene for prevention of bone loss in early postmenopausal women. STUDY DESIGN: We randomly assigned 278 healthy, early postmenopausal women to receive either 2 mg 17 beta-estradiol sequentially combined with 25 mu g gestodene (group 2/25s), 2 mg estradiol sequentially combined with 50 mu g gestodene (group 2/50s), 1 mg estradiol sequentially combined with 25 mu g gestodene (group 1/25s), 1 mg estradiol continuously combined with 25 mg gestodene (group 1/25c), or placebo. RESULTS: After 3 years the changes in bone mineral density of the spine were as follows (mean +/- SEM): group 2/25s, 7.41% +/- 0.72%; group 2/50s, 8.53% +/- 0.90%; group 1.258, 6.67% +/- 0.88%; group 1/25c, 4.44% +/- 0.59%; and placebo group, -2.03% +/- 0.64%. The changes in bone mineral density were mirrored in the biochemical bone markers. The average responses for the urinary C-terminal telopeptide fragments of type I collagen corrected for creatinine excretion were as follows (mean of baseline +/- SEM): group 2/25s, -68.8% +/- 0.03%; group 2/50s, -72.8% +/- 0.02%; group 1/25s, -60.7% +/- 0.03%; group 1/25c, -52.28% +/- 0.04%; and placebo group, 6.5% +/- 0.09%. Beneficial lipid effects were found in all active groups. The decreases in low-density lipoprotein were as follows (mean +/- SEM): group 2/25s, -13.7% +/- 3.0%; group 2/50s, -14.6% +/- 3.2%; group 1/25s, -9.28% +/- 2.2%; group 1/25c, -9.92% +/- 2.4%; and placebo group, 1.53% +/- 1.9%. CONCLUSION: These results demonstrate that estradiol therapy with 1 mg estradiol is fully protective against early postmenopausal bone loss.