RecruitingPhase 2NCT03841058

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

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

Sponsor

Hospital for Special Surgery, New York

Enrollment

96 participants

Start Date

Aug 14, 2019

Study Type

INTERVENTIONAL

Conditions

Spinal Fusion

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.

Eligibility

Min Age: 50 Years

Inclusion Criteria3

Postmenopausal women (defined as \>12 months since last menstrual cycle) OR men
Age of 50 years or older
Requiring posterolateral lumbar spine fusion surgery (L1-2; L2-3; L3-4; L4-5, L5-S1) with single or multi-level fusion for degenerative conditions of the lumbar spine (including lumbar degenerative disk disease, severe instability, high grade spondylolisthesis, deformity, degenerative scoliosis, pseudoarthrosis, and spinal stenosis) under the care of spine surgeons at the Hospital for Special Surgery.

Exclusion Criteria14

Hypersensitivity to abaloparatide
Patients with increased risk of osteosarcoma: Paget's disease, prior radiation therapy
Patients with active hypercalcemia or current diagnosis of hyperparathyroidism
History of multiple renal calculi or renal calculus within 2 years
Unexplained elevations in alkaline phosphatase
Evidence of metastatic cancer or multiple myeloma.
Patients unwilling to take placebo or abaloparatide.
Patients whose surgery is for a revision to a prior lumbar spinal fusion surgery
Chronic oral steroids (\>= 7.5 mg prednisone/d currently and for more than 1 month) for an inflammatory comorbid diagnosis
Patients who cannot understand and sign the informed consent
Patients who are unable to meet the proposed follow-up schedule
Patients with \>1 year of prior cumulative treatment with Forteo and/or Tymlos, or any use of Forteo or Tymlos within the 6 months prior to enrollment.
Patients who have received bisphosphonate treatment of \>1 year in past 5 years
Patients who are current smokers