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difficulty in enrollment
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be administered intravenously to people who have suffered an acute spinal cord fracture. The goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this population. Outcome measures will include bone density determinations over a one year period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zoledronic acid | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zoledronic acid | Drug | zoledronic acid, 5mg, iv |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mass Density (BMD) at Total Hip | bone mineral density measured by DXA at the total hip | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMD at Other Skeletal Sites | BMD at spine, femoral neck, distal femur, proximal tibia, heel | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J Schnitzer, MD, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26828618 | Result | Schnitzer TJ, Kim K, Marks J, Yeasted R, Simonian N, Chen D. Zoledronic Acid Treatment After Acute Spinal Cord Injury: Results of a Randomized, Placebo-Controlled Pilot Trial. PM R. 2016 Sep;8(9):833-43. doi: 10.1016/j.pmrj.2016.01.012. Epub 2016 Jan 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zoledronic Acid | zoledronic acid: zoledronic acid, 5mg, iv |
| FG001 | Placebo | placebo: iv |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zoledronic Acid | zoledronic acid: zoledronic acid, 5mg, iv |
| BG001 | Placebo | placebo: iv |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Mass Density (BMD) at Total Hip | bone mineral density measured by DXA at the total hip | Posted | Mean | Standard Deviation | %change in BMD from baseline | 6 months |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zoledronic Acid | zoledronic acid: zoledronic acid, 5mg, iv | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| baclofen pump implant | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| femoral fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
please see publication for discussion; small sample size major limitation
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Schnitzer | Northwestern University | 312-503-2315 | tjs@northwestern.edu |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D013119 | Spinal Cord Injuries |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| placebo | Drug | iv |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | BMD at Other Skeletal Sites | BMD at spine, femoral neck, distal femur, proximal tibia, heel | heel measurements were not performed | Posted | Mean | Standard Deviation | percentage of baseline BMD | 6 months |
|
|
|
| 8 |
| 1 |
| 8 |
| 6 |
| 8 |
| EG001 | Placebo | placebo: iv | 0 | 9 | 3 | 9 | 6 | 9 |
| decubitus ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| infection | Infections and infestations | Systematic Assessment | possible urinary tract infection |
|
| hospitalization | Investigations | Systematic Assessment | reason for hospitalization not obtained |
|
| urinary tract infection | Infections and infestations | Systematic Assessment |
|
| fever | General disorders | Systematic Assessment |
|
| headache | General disorders | Systematic Assessment |
|
| gasric ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| hypertension | Cardiac disorders | Systematic Assessment |
|
| chest pain | Cardiac disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| pressure ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| ingrown hair | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| kidney stone | Renal and urinary disorders | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| musculoskeletall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| hematuria | Renal and urinary disorders | Systematic Assessment |
|
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| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| right femoral neck BMD |
|
|
| distal femur |
|
|
| proximal tibia |
|
|
| heel |
|