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

Description

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.

Conditions

Spinal Fusion

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Spinal Fusion
Intervention / Treatment

-

Contacts and Locations

New York

Hospital for Special Surgery, New York, New York, United States, 10021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • 1. Hypersensitivity to abaloparatide
  • 2. Patients with increased risk of osteosarcoma: Paget's disease, prior radiation therapy
  • 3. Patients with active hypercalcemia or current diagnosis of hyperparathyroidism
  • 4. History of multiple renal calculi or renal calculus within 2 years
  • 5. Unexplained elevations in alkaline phosphatase
  • 6. Evidence of metastatic cancer or multiple myeloma.
  • 7. Patients unwilling to take placebo or abaloparatide.
  • 8. Patients whose surgery is for a revision to a prior lumbar spinal fusion surgery
  • 9. Chronic oral steroids (\>= 7.5 mg prednisone/d currently and for more than 1 month) for an inflammatory comorbid diagnosis
  • 10. Patients who cannot understand and sign the informed consent
  • 11. Patients who are unable to meet the proposed follow-up schedule
  • 12. 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.
  • 13. Patients who have received bisphosphonate treatment of \>1 year in past 5 years
  • 14. Patients who are current smokers

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hospital for Special Surgery, New York,

Emily Stein, MD, PRINCIPAL_INVESTIGATOR, Hospital for Special Surgery, New York

Study Record Dates

2026-09