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

Launched by HOSPITAL FOR SPECIAL SURGERY, NEW YORK · Feb 12, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called abaloparatide in postmenopausal women who need surgery to fuse bones in their lower back, as well as in men undergoing similar surgery. The goal is to find out if abaloparatide can help improve healing and bone strength after surgery compared to a placebo, which looks like the medication but has no active ingredients. The trial will involve 72 women and 24 men, and will track their recovery over one year, focusing on pain levels and how well their bones fuse together.

To be eligible for this study, participants need to be at least 50 years old, postmenopausal women or men, and scheduled for specific types of spinal fusion surgery due to various back problems. Unfortunately, not everyone can join; for instance, those with certain health conditions or who are currently taking specific medications may be excluded. Participants can expect to receive either the medication or the placebo daily for six months, and they'll have regular follow-ups to check on their progress. This study is currently recruiting participants, and it's an opportunity to contribute to research that could improve recovery for future patients.

Gender

ALL

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