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The Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With PFNA

NCT03133195 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-01-15

No results posted yet for this study

Summary

Phase III, prospective, randomized, parallel, double blind, placebo-controlled study to determine whether Teriparatide can accelerate bone healing in unstable intertrochanteric fracture patients treated with Proximal Femoral Nail Antirotation (PFNA) assessed by radiographic and clinical outcomes.

Conditions

  • Unstable Intertrochanteric Fracture
  • Pertrochanteric Fracture of Femur, Closed

Interventions

DRUG

Teriparatide

Teriparatide 20 μg subcutaneous once daily for 12 weeks (Patient self administration at home by pen injector)

DRUG

Placebo

Placebo subcutaneous once daily for 12 weeks. (Patient self administration at home by pen injector)

DIETARY_SUPPLEMENT

Calcium supplement

1000 mg/day of elemental calcium

DIETARY_SUPPLEMENT

Vitamin D

20,000 IU/week of vitamin D2

Sponsors & Collaborators

  • King Chulalongkorn Memorial Hospital

    lead OTHER

Principal Investigators

  • Prof.Dr.Aree Tanavalee, M.D. · Chulalongkorn University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-17
Primary Completion
2022-06-01
Completion
2023-07-01

Countries

  • Thailand

Study Locations

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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 NCT03133195 on ClinicalTrials.gov