Conditions: Spinal Cord Injury Bone Loss Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Teriparatide alone with sham vibration arm 2: Vibration alone with placebo-teriparatide arm 3: Teriparatide with vibration applied in conjuction

Interventions: intervention 1: Teriparatide intervention 2: vibration
Intervention descriptions: intervention 1: 20 ug daily over 12 months intervention 2: 10 min/day for 12 months

Protocol document: