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Supracondylar Distal Femur Fractures and Abaloparatide

NCT04626141 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-05-01

No results posted yet for this study

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).

Conditions

  • Femoral Fractures

Interventions

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.

Sponsors & Collaborators

  • Radius Health, Inc.

    collaborator INDUSTRY

  • Daniel Horwitz

    lead OTHER

Principal Investigators

  • Daniel Horwitz, MD · Geisinger Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04626141 on ClinicalTrials.gov