Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density

Study Overview
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Brief Summary
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This is a randomized study to determine the effects of monthly romosozumab for one year or one-time zoledronic acid on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.

Detailed Description
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This is a randomized open-label study to determine the effects of monthly romosozumab for 12 month or one-time zoledronic acid infusion on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD. Patients: Thirty women between 20-70 years of age with spinal cord injury and low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites) will receive study medication. Primary outcome: Total hip BMD change during a one-year treatment period. Secondary outcome: Change in Femoral neck BMD at 12 months, Bone turnover markers change over time (3, 9 and 12 month): C-terminal telopeptide of type I collagen (CTX), N-terminal propeptide of type I procollagen (P1NP). Study population: Thirty women between 20-70 years of age with spinal cord injury that occurred more than 24 month ago and low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites)

Official Title
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Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density

Conditions
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Osteoporosis Fracture, Spinal Cord Injuries

Intervention / Treatment
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* Drug: Romosozumab
* Drug: Zoledronic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMD T-score ≤ -2.0 at the lumbar spine, total hip or femoral neck SCI of at least 24-month but less than 7 years duration, American Spinal Injury Association (ASIA) Impairment Scale A-C Exclusion Criteria: myocardial infarction (MI) or stroke within the preceding year high cardiovascular risk, 10 years Framingham score over 20 %.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

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
Interventional Model Description: open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SC Romosozumab 210 mg/monthly<br>SC Romosozumab 210 mg/monthly | Drug: Romosozumab<br>* SC Romosozumab 210 mg/monthly<br>|
| Active Comparator: IV Zoledronic acid 5 mg<br>IV Zoledronic acid 5 mg | Drug: Zoledronic Acid<br>* IV Zoledronic acid 5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total hip BMD change during a one-year treatment period | BMD change | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Femoral neck BMD at 12 months | BTM change | one year | 
| Bone turnover markers change | Bone turnover markers change over time (3, 9 and 12 month) | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone mineral density, fracture, romosozumab