CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Teriparatide +1 moredrug
Likely dose
Not stated in 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/NCT02025179
NCT02025179Phase 2Completed
CompareCT.gov

12 Month Open-Label Extension Study of the Effect of Teriparatide on Bone in People With Chronic SCI

Northwestern University·interventional·Posted Dec 31, 2013·Updated May 10, 2023

In Brief

A Phase 2 clinical trial evaluating Teriparatide and Vibration for Spinal Cord Injury and 2 related conditions. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if a second year of exposure to teriparatide in both subjects that received a year of teriparatide or teriparatide-placebo will result in a greater increase in bone mass density (BMD) compared to that seen in a single year's treatment. This study will also investigate 1) if a second year of teriparatide therapy will increase bone strength in people with chronic spinal cord injury (SCI) who previously received a year of teriparatide or teriparatide-placebo, 2) the number of participants with adverse events from teriparatide, and 3) the effects of teriparatide on serum markers of bone metabolism.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Injury, Bone Loss, Osteoporosis
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 31, 2013
Enrollment StartJan 1, 2013
Primary CompletionAug 14, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.5 years ago

Interventions

Teriparatidedrug

Teriparatide 20 ug daily Sub-Q over 12 months

Vibrationdevice

Vibration 10 min/day for 12 months