NCT00826228

Effect of Parathyroid Hormone (PTH) and Weight-Bearing on Bone in Spinal Cord Injury (SCI)

Effect of PTH Combined With Weight-Bearing on Bone Density and Bone Architecture in People With Spinal Cord Injury

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Thomas J. Schnitzer · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Individuals with spinal cord injury sustain significant loss of bone mass in their lower extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two interventions that build bone, to increase bone mass in this population.

Detailed description

This pilot project aims to evaluate PTH with weight-bearing in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 12 people with SCI will be enrolled into a 6 month study assessing the effects of a weight-bearing regime plus daily PTH (Forteo 20ug sc) on BMD and bone markers. Subjects will be evaluated at 3 and 6 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption. An optional extension to 12 months will be offered to all subjects.

Conditions

• Osteoporosis
• Bone Loss
• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	teriparatide	teriparatide 20ug daily sc for 6 months
OTHER	weight-bearing	device assisted walking

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-03-01
• Completion: 2012-12-01
• First posted: 2009-01-22
• Last updated: 2013-07-11
• Results posted: 2013-07-11

Locations

1 site across 1 country: United States