Overview

This trial is active, not recruiting.

Conditions spinal cord injury, bone loss, osteoporosis
Treatments teriparatide, vibration
Phase phase 2
Sponsor Northwestern University
Collaborator United States Department of Defense
Start date January 2013
End date June 2016
Trial size 40 participants
Trial identifier NCT02025179, A1195

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months
teriparatide Forteo
Teriparatide 20 ug daily Sub-Q over 12 months
vibration Soloflex WBV platorm
Vibration 10 min/day for 12 months

Primary Outcomes

Measure
Bone Mass Density (BMD)
time frame: 6 and 12 months

Secondary Outcomes

Measure
Serum markers of bone metabolism
time frame: 6 and 12 months

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Enrollment in, and completion of one year of treatment, in protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury". - Adherence rate for teriparatide use of ≥60%. - 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. - A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: - Has not undergone a hysterectomy or bilateral oophorectomy; or - Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). - Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: - Individuals who could not tolerate teriparatide 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

Additional Information

Official title 12 Month Open-Label Extension Study of the Effect of Teriparatide on Bone in People With Chronic SCI
Principal investigator Thomas J Schnitzer, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Northwestern University.