12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)
This trial is active, not recruiting.
|Conditions||spinal cord injury, bone loss, osteoporosis|
|Collaborator||United States Department of Defense|
|Start date||January 2013|
|End date||June 2016|
|Trial size||40 participants|
|Trial identifier||NCT02025179, A1195|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Bone Mass Density (BMD)
time frame: 6 and 12 months
Serum markers of bone metabolism
time frame: 6 and 12 months
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
|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|
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