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Abaloparatide and Pelvic Fracture Healing

NCT04249232 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-06-14

No results posted yet for this study

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.

Conditions

  • Fracture of Pelvis (Disorder)

Interventions

DRUG

Abaloparatide 80 micrograms per Pen dose

prefilled injector pen to deliver 80 micrograms daily subcutaneously

DRUG

Placebo prefilled injector pen

prefilled injector pen to deliver inactive solution daily subcutaneously

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Icahn School of Medicine at Mount Sinai

    collaborator OTHER

  • New York University

    collaborator OTHER

  • Westchester Medical Center

    collaborator OTHER

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Jeri W Nieves, PhD · Hospital for Special Surgery, New York

  • Joseph Lane, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-17
Primary Completion
2024-04-25
Completion
2024-04-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04249232 on ClinicalTrials.gov