Comparing abaloparatide and placebo for spinal fusion in postmenopausal women and men

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

This study is testing if a new medication called abaloparatide can help postmenopausal women and men recover better from spinal fusion surgery by improving bone healing and reducing pain.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Hospital for Special Surgery, New York (other)
• Drugs / interventions: radiation, prednisone
• Locations: 1 site (New York, New York)
• Trial ID: NCT03841058 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of abaloparatide in postmenopausal women undergoing lumbar spinal fusion surgery. A total of 72 women with low bone mass will be randomly assigned to receive either abaloparatide or a placebo for six months, while an additional 24 men will be treated with abaloparatide in an open-label design. The study aims to evaluate surgical outcomes, pain reduction, and bone fusion rates over a 12-month period. Key outcomes include the assessment of fusion success via CT scans and pain levels measured by standardized scales.

Who should consider this trial

Good fit: Ideal candidates include postmenopausal women aged 50 and older requiring lumbar spinal fusion surgery, as well as men aged 55 and over.

Not a fit: Patients with hypersensitivity to abaloparatide or those with conditions that increase the risk of osteosarcoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve surgical outcomes and pain management for patients undergoing spinal fusion.

How similar studies have performed: While this approach is novel in the context of spinal fusion, similar studies have shown promise in using abaloparatide for bone health.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

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

Where this trial is running

New York, New York

• Hospital for Special Surgery — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Emily Stein, MD — Hospital for Special Surgery, New York
• Study coordinator: Giavanna D'Erasmo

Conditions: Spinal Fusion, abalopartide, pain, surgical outcome