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

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: Female

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. Seventy-two 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. Outcomes include surgical outcome at one year, pain, and fusion bone mass volume (FBMV) as a marker of bone union at 6 months and 1 year.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Treatments: Abaloparatide

Criteria

Inclusion Criteria:

• Postmenopausal women (defined as >12 months since last menstrual cycle)

• 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