Status:
RECRUITING
Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Spinal Fusion
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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 tot...
Detailed 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. Seven...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03841058
Start Date
August 14 2019
End Date
September 1 2026
Last Update
July 25 2025
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021