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12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)

Information source: Northwestern University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

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

Intervention: Teriparatide (Drug); Vibration (Device)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Northwestern University

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

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.

Clinical Details

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

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: Serum markers of bone metabolism

Eligibility

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

Criteria:

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

Locations and Contacts

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

Starting date: January 2013
Last updated: April 22, 2015

Page last updated: August 20, 2015

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