Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT03841058
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03841058
Study Brief:
Protocol Section:
NCT03841058