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

Northwestern University

Status and phase

Completed

Phase 2

Conditions

Osteoporosis

Spinal Cord Injury

Bone Loss

Treatments

Drug: Alendronate

Dietary Supplement: Vitamin D

Dietary Supplement: Calcium

Study type

Interventional

Funder types

Other

Identifiers

NCT02195895

STU00083759

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Prior enrollment in protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury", (NCT01225055).
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
Ability to understand and the willingness to sign a written informed consent.

Exclusion criteria

Individual with renal insufficiency (calculated creatinine clearance < 30 ml/min).
Individuals who are not able to sit or stand upright for at least 30 minutes after taking their medication.
Individuals with poor dental hygiene.
Individuals with esophageal abnormalities.
Individuals who are not able to tolerate alendronate treatment.
Individuals who will not be able to return for all study visits.
Patients may not be receiving any other investigational agents.
Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study