CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Teriparatide Prefilled Syringe +1 moredrug
Likely dose
Teriparatide Prefilled Syringe 20 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02972424
NCT02972424Phase 2Completed

PTH(1-34) and Pelvic Fracture Healing - a Randomized Controlled Trial

Hospital for Special Surgery, New York·interventional·Posted Nov 23, 2016·Updated Jul 27, 2022

In Brief

A Phase 2 clinical trial evaluating Teriparatide Prefilled Syringe and Placebo for Osteoporotic Fractures. Completed, enrolled 35 participants across 1 site.

Detailed Summary

In the proposed trial the investigators will recruit women and men \>65 years of age with acute osteoporosis-related pelvic fractures and address 3 specific aims over 3 months of treatment in a placebo controlled double blind study to determine if standard care and teriparatide 20 mcg/day versus placebo for pelvic fractures: 1. Results in earlier evidence of cortical bridging on routine radiographs followed by confirmatory Focus CT, a novel method to reduce radiation exposure from CT scans (primary outcome). 2. Leads to a faster reduction in pain as assessed by both the Numeric Rating Scale and a reduction in the use of narcotics (secondary outcome). 3. Leads more rapidly to improved functional outcome using a short physical performance battery to assess lower extremity function (secondary outcome).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 23, 2016
Enrollment StartMay 1, 2017
Primary CompletionMar 8, 2021
Study CompletionJul 8, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 9.6 years ago

Interventions

Teriparatide Prefilled Syringedrug

TPTD 20 mcg

Placebodrug

Matching placebo as a prefilled syringe with all inactive ingredients