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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 be enrolled into a 6 month study assessing the effects of a weight-bearing regime plus daily PTH (Forteo 20ug sc) on BMD and bone markers. Subjects will be evaluated at 3 and 6 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption. An optional extension to 12 months will be offered to all subjects.

Official Title
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Effect of PTH Combined With Weight-Bearing on Bone Density and Bone Architecture in People With Spinal Cord Injury

Conditions
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Osteoporosis, Bone Loss, Spinal Cord Injury

Intervention / Treatment
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* Drug: teriparatide
* Other: weight-bearing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTH/Weight-Bearing<br> | Drug: teriparatide<br>* teriparatide 20ug daily sc for 6 months<br>* Other names: Forteo;Other: weight-bearing<br>* device assisted walking<br>* Other names: exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD at Left Total Hip | Bone mineral density (gm/cm2) of the total hip region of interest on the left | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P1NP | amino-terminal propeptide of type I collagen (P1NP) | Baseline to 6 months |