Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

REPLENISH: Oral estradiol/progesterone slowed bone turnover as it cut VMS

Key clinical point: Women taking an oral estradiol/progesterone combination had statistically significant reductions in their blood levels of three markers of bone turnover, compared with placebo.

Major finding: After 12 months, mean biomarker levels fell by 18%-41% relative to placebo depending on the specific marker tested.

Study details: A post hoc, subgroup study with 157 of the 1,845 women enrolled in REPLENISH, a multicenter, randomized trial.

Disclosures: REPLENISH was funded by TherapeuticsMD, the company that markets the tested estradiol plus progesterone formulation (Bijuva). Dr. Kagan has been a consultant and adviser to and speaker on behalf of Therapeutics MD, and she has been a consultant or adviser to or has spoken on behalf of AMAG, Amgen, Astellas, Lupin, Radius, and Warner Chilcott/Allergan, and she has received research funding from Endoceutics.