NCT01225055

Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Thomas J. Schnitzer · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on bone mass.

Detailed description

The aim of this study is to evaluate PTH with vibration in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 60 subjects with SCI will be enrolled into a 12 month study assessing the effects of PTH (20 ug/day) and vibration (10 min/day) individually or in combination on BMD and bone markers. Subjects will be evaluated at 3, 6, 9, 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	20 ug daily over 12 months
DEVICE	vibration	10 min/day for 12 months

Timeline

• Start date: 2010-10-01
• Primary completion: 2015-08-01
• Completion: 2016-08-01
• First posted: 2010-10-20
• Last updated: 2025-12-02
• Results posted: 2017-06-22

Locations

2 sites across 1 country: United States