Clinical Trial

Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery

Study acronym: FAST-Healing
Active, Not Recruiting Phase 2
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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. A total of 72 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. As well as a total of 24 men in an open-label design will be enrolled as an extension to this study. The total anticipated enrollment updated to 97. Outcomes include surgical outcomes at one year, pain, and fusion bone mass volume (FBMV) as a marker of bone union at 6 months and 1 year.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2019-02-12; most recent amendment 2026-04-23.
Status change: Recruiting → Active, Not Recruiting 2026-04-23
Status change: Suspended → Recruiting 2020-07-08
Status change: Recruiting → Suspended 2020-04-20
Status change: Not Yet Recruiting → Recruiting 2019-10-25
Trial Details
NCT Number NCT03841058
Lead Sponsor Hospital for Special Surgery, New York
Conditions Spinal Fusion
Enrollment 96 participants
Start Date 2019-08-14
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-04-28