NCT04626141

Supracondylar Distal Femur Fractures and Abaloparatide

Time to Healing, Loss of Fixation, and Loss of Alignment in Supracondylar Distal Femur Fractures Among a Geriatric Population Treated With Abaloparatide: A Double-Blind Placebo Controlled Study

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Daniel Horwitz · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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. Multiple methods of fixation are well accepted, and each has its own advantages and disadvantages. The common occurrence of periprosthetic supracondylar femur fractures adds another level of complexity, and the universal goal when treating these patients is to obtain and maintain acceptable alignment, allow mobilization and early weight bearing, and achieve union. To a degree, mobilization and weight bearing compete with maintenance of axial alignment, and any final outcome is a race between healing and loss of fixation. As a result, any intervention that can accelerate healing would be of great benefit. As the vast majority of these injuries heal with secondary bone healing (callous), the determination of "healing" is reliably determined using the modified Radiographic Union Score for Tibia Fractures (mRUST), and thus this patient population offers an ideal population in which to evaluate an accelerant of fracture healing. 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).

Conditions

• Femoral Fractures

Interventions

Type	Name	Description
DRUG	Abaloparatide	Abaloparatide will be dispensed as a 30-day supply of disposable pen injections of the standard, FDA approved dosage (80 mcg abaloparatide).
DRUG	Placebo	Placebo will be dispensed as a 30-day supply of disposable pen injections.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2020-11-12
• Last updated: 2024-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study