drugset / Trial / NCT02025179

12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)

NCT02025179

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-01
Primary completion
2015-08-14
Completion
2015-08-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Teriparatide Protein / enzyme biologic 20 ug Subcutaneous