NCT02025179

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This extension study will only enroll individuals who have completed one year of treatment in the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury (NCT01225055)". This study will allow those individuals who received Teriparatide (20ug/day) and vibration (10 min/day) during the parent study to be treated for a second year and will allow those individuals who received teriparatide-placebo to have the opportunity to have a full year of teriparatide therapy. This study will determine if two years of exposure to teriparatide will result in a greater increase in Bone Mass Density (BMD) than that seen after a single year's treatment. Subjects will be evaluated at 6 and 12 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.

Conditions

• Spinal Cord Injury
• Bone Loss
• Osteoporosis

Interventions

Type	Name	Description
DRUG	Teriparatide	Teriparatide 20 ug daily Sub-Q over 12 months
DEVICE	Vibration	Vibration 10 min/day for 12 months

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-08-14
• Completion: 2015-08-14
• First posted: 2013-12-31
• Last updated: 2023-05-10
• Results posted: 2018-09-25

Locations

1 site across 1 country: United States