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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC Romosozumab 210 mg/monthly | Experimental | SC Romosozumab 210 mg/monthly |
|
| IV Zoledronic acid 5 mg | Active Comparator | IV Zoledronic acid 5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romosozumab | Drug | SC Romosozumab 210 mg/monthly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total hip BMD change during a one-year treatment period | BMD change | one year |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liana Tripto-Shkolnik, MD | Contact | +972526334348 | TriptoShkolnik.Liana@sheba.health.gov.il | |
| Noa Konvalina | Contact | +97235302021 | endo.r@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Liana Tripto-Shkolnik, MD | Sheba Medical Center, Tel Hashomer | Principal Investigator |
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| ID | Term |
|---|---|
| D058866 | Osteoporotic Fractures |
| D013119 | Spinal Cord Injuries |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C557282 | romosozumab |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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open label
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| Zoledronic Acid |
| Drug |
IV Zoledronic acid 5 mg |
|
| one year |
| D020196 | Trauma, Nervous System |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |