Phase II Trial of Abaloparatide vs. Placebo in Post-Menopausal Women Receiving Initial Spinal Fusion Surgery
Status:
Recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
Summary
This is a prospective randomized, double-blinded, placebo-controlled, phase 2, 12-month pilot
to study the efficacy of abaloparatide in postmenopausal women needing lumbar spinal fusion
surgery. Seventy-two women with low bone mass who are scheduled to undergo spinal fusion
surgery will be randomized 2:1 in a blinded fashion to receive either 80 mcg of abaloparatide
subcutaneously (SC) every day or an identical-appearing placebo SC for 6 months. Outcomes
include surgical outcome at one year, pain, and fusion bone mass volume (FBMV) as a marker of
bone union at 6 months and 1 year.