Abaloparatide and Pelvic Fracture Healing

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective randomized, double-blinded, placebo-controlled, phase 2, three-month study of the efficacy of abaloparatide in postmenopausal women and men ≥ 50 years of age with acute fractures of the pelvis (n=78). The primary outcome is CT image based evidence of fracture healing. The secondary aims are pain and physical performance measures at 3 months. This study will be extended with 9 months of open label abaloparatide to determine if any potential differences between the placebo and abaloparatide groups during the 3 months of treatment are evident and persist over time, even in patients who use abaloparatide after the three-month placebo controlled intervention.

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

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Collaborators: Icahn School of Medicine at Mount Sinai; Lenox Hill Hospital; New York Hospital Queens; New York University; Weill Medical College of Cornell University
• Treatments: Abaloparatide; Parathyroid Hormone-Related Protein

Criteria

Inclusion Criteria:

• Postmenopausal women and men >50 years of age with acute pelvic fractures, occurring with minimal trauma, presenting to Mount Sinai, New York University, New York Presbyterian-Queens, Hospital for Special Surgery, or New York Hospital (Cornell Medical) within one month of the onset of symptoms.

Exclusion Criteria:

1. Persons unable to complete the NRS and other surveys based on assessment by the study doctor.

2. Previously (prior to fracture) non-ambulatory subjects

3. Exclusion criteria related to contraindication or intolerance to ABALOPARATIDE:

1. Hypersensitivity to ABALOPARATIDE

2. Patients with increased risk of osteosarcoma: Paget's disease, history of radiation exposure

3. Patients with active hypercalcemia

4. Current hyperparathyroidism and other metabolic bone disease including osteogenesis imperfecta

5. History of multiple renal calculi or renal calculus within the last 2 years

6. Normal alkaline phosphatase levels will not be used as an entrance criterion because most fracture patients will have elevations due to the acute fracture. However, investigators will attempt to obtain lab tests from the period prior to fracture to determine if they were normal. If unexplained elevations in alkaline phosphatase are found in labs prior to the fracture, the investigators will exclude that subject.

7. Evidence of metastatic cancer or history of bone cancer or any active cancer other than basal or squamous cell carcinoma.