Status:
COMPLETED
Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
Lead Sponsor:
Thomas J. Schnitzer
Collaborating Sponsors:
Edward Hines Jr. VA Hospital
University of Illinois at Chicago
Conditions:
Spinal Cord Injury
Bone Loss
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on bone mass.
Detailed Description
The aim of this study is to evaluate PTH with vibration in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 60 subjects with SCI will b...
Eligibility Criteria
Inclusion
- Age \>21 years (must have closed epiphyses; PTH contraindicated if epiphyses open)
- Both males and females
- SCI with inability to ambulate independently
- Capable of positioning to have DXA performed
- Low bone mass at the total hip by DEXA (Z score \< 1.5; T score \< 2.5 or T score \<-2.0 plus preexisting fragility fracture)
- Capable of reading and understanding informed consent document
- Able to self-administer teriparatide or have someone in the family who can do so
- No known endocrinopathies
- Normal TSH levels
- Normal 25-OH vitamin D levels (\> 30ng/ml)
- Normal calcium levels
- Normal renal function (creatinine \<2.0mg/dl)
- Able to return for all follow-up visits
Exclusion
- Surgical or other intervention resulting in metal or anatomy precluding obtaining DXA measurements (e.g., cardiac pacemakers, ferromagnetic implants or brain aneurysm clips).
- Had had an allergic reaction to Teriparatide (FORTEO) or one of its ingredients.
- Have Paget's disease of the bone
- Have unexplained high levels of f alkaline phosphatase in blood
- Any active Gastrointestinal condition that results in malabsorption
- History of presence of alcoholism or drug abuse within the 2 years prior to study screening
- Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
- History of malignancy. Patients having had basal cell carcinomas successfully removed will be allowed to enroll in the protocol.
- History of radiation therapy
- Unable to self-administer PTH or have it administered
- Elevated liver function tests \>2x normal
- Currently being prescribed anti-convulsants
- Currently being prescribed glucocorticoids, other than inhaled glucocorticoids
- Currently being prescribed any bone-active agents, including any bisphosphonate, raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or strontium-containing compounds. Bisphosphonate use will be allowed up the time of initiation of study medication but not during the dosing with study medication.
- Previous history of PTH use
- Pregnant, planning to become pregnant, or lactating
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01225055
Start Date
October 1 2010
End Date
August 1 2016
Last Update
December 2 2025
Active Locations (2)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
2
Edward Hines, Jr, VA Hospital
Maywood, Illinois, United States, 60153