Status:
COMPLETED
Effect of Parathyroid Hormone (PTH) and Weight-Bearing on Bone in Spinal Cord Injury (SCI)
Lead Sponsor:
Thomas J. Schnitzer
Collaborating Sponsors:
Eli Lilly and Company
Shirley Ryan AbilityLab
Conditions:
Osteoporosis
Bone Loss
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Individuals with spinal cord injury sustain significant loss of bone mass in their lower extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two interventions tha...
Detailed Description
This pilot project aims to evaluate PTH with weight-bearing in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 12 people with SCI will...
Eligibility Criteria
Inclusion
- Age 18-75 years
- Complete SCI - total loss of motor function below level of lesion
- Capable of positioning to have DEXA performed
- Capable of undertaking the weight-bearing exercise regime
- Capable of reading and understanding informed consent document
- Able to self-administer PTH or have someone in the family who can do so
- T score \<-2.5 or Z score \<-1.5 on evaluation of total hip BMD
- No known endocrinopathies
- Normal TSH levels
- Normal 25-OH vitamin D levels
- 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 DEXA and/or MRI measurements
- Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
- History of malignancy
- History of radiation therapy
- Unable to self-administer PTH or have it administered
- Elevated liver function tests \>2x normal
- For males, significantly abnormal free testosterone levels
- 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.
- No previous history of bisphosphonate use
- No previous use of other bone-specific agents during past 2 years
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00826228
Start Date
June 1 2009
End Date
December 1 2012
Last Update
July 11 2013
Active Locations (1)
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1
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611