Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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 be enrolled into a 12 month study assessing the effects of PTH (20 ug/day) and vibration (10 min/day) individually or in combination on BMD and bone markers. Subjects will be evaluated at 3, 6, 9, and 12 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.

Official Title
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Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury

Conditions
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Spinal Cord Injury, Bone Loss, Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide
* Device: vibration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teriparatide<br>Teriparatide alone with sham vibration | Drug: Teriparatide<br>* 20 ug daily over 12 months<br>* Other names: Forteo;|
| Experimental: Vibration<br>Vibration alone with placebo-teriparatide | Device: vibration<br>* 10 min/day for 12 months<br>|
| Experimental: Teriparatide and vibration<br>Teriparatide with vibration applied in conjuction | Drug: Teriparatide<br>* 20 ug daily over 12 months<br>* Other names: Forteo;Device: vibration<br>* 10 min/day for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density BMD of the Total Hip as Assessed by DXA. | The mean change in BMD of the total hip after 12 month of treatment | Baseline to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density (BMD) by DXA at the Lumbar Spine. | The mean change in BMD at the lumbar spine from baseline after 12 month of treatment | Baseline to 12 Months | 
| Bone Mineral Density (BMD) by DXA at Femoral Neck | The mean change in BMD of the femoral neck after 12 month of treatment | Baseline to 12 Months | 
| C-terminal Telopeptide | The mean change in C-terminal telopeptide from baseline after 12 month of treatment | Baseline to 12 Months | 
| Bone-specific Alkaline Phosphatase | The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy | Baseline to 12 Months | 
| Amino-terminal Propeptide of Type 1 Collagen | The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment | Baseline to 12 Months |