Conditions: Spinal Cord Injury Bone Loss Osteoporosis
Keywords: Teriparatide Osteoporosis Spinal Cord Injury Bone Diseases Metabolic Bone Diseases Musculoskeletal Diseases Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Nervous System Wounds and Injuries Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Vibration
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Experimental: Teriparatide and vibration

Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months

Device: Vibration 10 min/day for 12 months

Interventions: intervention 1: Teriparatide intervention 2: Vibration
Intervention descriptions: intervention 1: Teriparatide 20 ug daily Sub-Q over 12 months intervention 2: Vibration 10 min/day for 12 months

Protocol document: