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

Condition(s) targeted: Spinal Cord Injury; Bone Loss; Osteoporosis

Intervention: Alendronate (Drug); Calcium (Dietary Supplement); Vitamin D (Dietary Supplement)

Phase: Phase 2

Status: Enrolling by invitation

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Thomas J Schnitzer, MD, PhD, Principal Investigator, Affiliation: Northwestern University Feinberg School of Medicine

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

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bone mass density (BMD)

Secondary outcome:

Bone strength

Safety of alendronate

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.

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Prior enrollment in protocol "Effect of Teriparatide, Vibration and the Combination

on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury", (NCT ID # 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

Northwestern University Feinberg School of Medicine, Chicago, Illinois 60611, United States

Starting date: April 2014
Last updated: April 22, 2015