Status:
COMPLETED
Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide
Lead Sponsor:
Northwestern University
Conditions:
Spinal Cord Injury
Bone Loss
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
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...
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 Sp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2016
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02195895
Start Date
April 1 2014
End Date
August 5 2016
Last Update
March 30 2023
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611