Supracondylar Distal Femur Fractures and Abaloparatide

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Pulsed dosing of parathyroid hormone derivatives (Forteo) has been shown to increase bone mass, and several studies in Europe have demonstrated its benefit as an adjuvant for fracture healing. Abaloparatide represents a new compound which similarly offers great potential for accelerating fracture healing, especially healing associated with callous formation. This is a randomized, double blind placebo-controlled trial to compare a group of patients being treated for supracondylar distal femur fractures who receive abaloparatide (n=38) with a control group of patients who receive a placebo (n=38).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel Horwitz
• Collaborator: Radius Health, Inc.
• Treatments: Abaloparatide

Criteria

Inclusion Criteria:

1. Subject is ≥ 65 years old

2. Subject is willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure

3. Subject is being treated for a closed supracondylar distal femur fracture with either a retrograde nail or locked plate

4. Subject undergoes open reduction/fixation

Exclusion Criteria:

1. Subject has open fracture

2. Bilateral injury or other lower extremity injury that would affect weight bearing status

3. Subject's postoperative radiographs (on day of surgery) indicate failure to achieve axial alignment (more than 10 degrees axial alignment and more than 25% anterior/posterior displacement in lateral view)

4. Subject has additional severe traumatic conditions such as closed head injury

5. Subject has medical condition or is on medication that may significantly affect healing (i.e. immunosuppressive diseases and drugs)

6. Subject has active or history of Paget's disease of the bone, bone cancer, or other bone diseases or conditions placing them at increased risk of osteosarcoma

7. Subject has active or history of hypercalcemia or underlying hypercalcemic disorder, such as primary hyperparathyroidism

8. Subject has active or a history of urolithiasis

9. Subject will have trouble injecting the pen and does not have someone to help them on a daily basis