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RECRUITING
NCT03841058
PHASE2

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

Sponsor: Hospital for Special Surgery, New York

View on ClinicalTrials.gov

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.

Official title: Phase II Trial of Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2019-08-14

Completion Date

2026-09

Last Updated

2025-07-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Abaloparatide

80 mcg delivered SC by a pen

DRUG

Placebo

A pen to deliver a SC dose of placebo

Locations (1)

Hospital for Special Surgery

New York, New York, United States