Effect of Parathyroid Hormone (PTH) and Weight-Bearing on Bone in Spinal Cord Injury (SCI)

Completed · Phase 4

Conditions studied: Osteoporosis, Bone Loss, Spinal Cord Injury

In brief

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 that build bone, to increase bone mass in this population.

Key facts

Study ID

NCT00826228

Run by

Thomas J. Schnitzer

People needed

12

Starts

2009-06-01

Expected to finish

2012-12-01

Last updated by the study team

2013-07-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rehabilitation Institute of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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