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Fracture (FX) Improvement With Teriparatide: FiX-IT Study

NCT01705587 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-12-12

Study results available
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Summary

This open label comparison study examines the hypothesis that teriparatide given immediately following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will enhance healing and improve bone mineral density compared to delayed treatment (after six months) with teriparatide or no treatment with teriparatide (patients who refuse therapy or for whom teriparatide is contraindicated). Patients with up-front teriparatide in addition will have greater quality of life measures and less pain compared to those with delayed or no therapy.

Conditions

Interventions

DRUG

teriparatide

20 microgram once-daily subcutaneous injection

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Susan L. Greenspan

    lead OTHER

Principal Investigators

  • Susan L. Greenspan, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Diseases
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 NCT01705587 on ClinicalTrials.gov