Conditions: Spinal Cord Injury Bone Loss Osteoporosis
Keywords: Teriparatide Alendronate Alendronic Acid Osteoporosis Bone Fracture Bone Loss 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
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 17
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if a year of alendronate treatment will maintain or increase bone mass density (BMD) compared to baseline BMD values in people with chronic spinal cord injury (SCI).

This study will also investigate 1) if alendronate therapy will increase bone strength in people with chronic SCI, 2) the number of participants with adverse events from alendronate, and 3) the effects of alendronate on serum markers of bone metabolism.

Detailed description:
This extension study will enroll individuals who have completed treatment in the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury" or in the teriparatide extension protocol. This study will allow those individuals who previously received teriparatide to be treated for a year with alendronate to maintain any bone they may have gained and to possibly increase bone mass further. Termination of teriparatide is followed by bone loss if anti-resorptive therapy is not initiated, so this approach is optimal for continued treatment of the current group of participants.

Arms:
arm 1: Drug: Weekly oral alendronate 70 mg for 12 months

Supplements: 1000 mg Calcium and 1000 IU Vitamin D daily for 12 months

Interventions: intervention 1: Alendronate intervention 2: Calcium intervention 3: Vitamin D
Intervention descriptions: intervention 1: Weekly oral alendronate 70 mg for 12 months intervention 2: Daily oral 1000 mg Calcium intervention 3: Daily oral 1000 IU

Protocol document: