NCT02195895

Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide

12 Month Open-Label Extension Study of the Effect of Alendronate on Bone in People With Chronic SCI Previously Treated With Teriparatide

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injury
• Bone Loss
• Osteoporosis

Interventions

Type	Name	Description
DRUG	Alendronate	Weekly oral alendronate 70 mg for 12 months
DIETARY_SUPPLEMENT	Calcium	Daily oral 1000 mg Calcium
DIETARY_SUPPLEMENT	Vitamin D	Daily oral 1000 IU

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-08-05
• Completion: 2016-08-05
• First posted: 2014-07-21
• Last updated: 2023-03-30
• Results posted: 2018-09-26

Locations

1 site across 1 country: United States