Zoledronic Acid in Acute Spinal Cord Injury
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ClinicalTrials.gov Identifier: NCT01642901 |
Recruitment Status :
Active, not recruiting
First Posted : July 17, 2012
Last Update Posted : September 13, 2018
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Sponsor:
Thomas Jefferson University
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Thomas Jefferson University
Tracking Information | ||||
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First Submitted Date ICMJE | July 6, 2012 | |||
First Posted Date ICMJE | July 17, 2012 | |||
Last Update Posted Date | September 13, 2018 | |||
Study Start Date ICMJE | May 2012 | |||
Actual Primary Completion Date | March 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
change in bone mineral density [ Time Frame: one year ] Change in bone mineral density (BMD) assessed by dual energy X-ray absorptiometry (DXA) at baseline, 4 months, and 12 months post-injury.
This will compare BMD at the hip, distal femur and proximal tibia.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Zoledronic Acid in Acute Spinal Cord Injury | |||
Official Title ICMJE | Zoledronic Acid to Prevent Bone Loss After Acute Spinal Cord Injury | |||
Brief Summary | Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture prevention and the associated morbidity of bed rest and further secondary complications. Intravenous (IV) zoledronic acid (ZA) is an FDA-approved drug that has been shown to be more effective than other agents in reducing bone mass resorption and leg fractures in post-menopausal women, but has not been studied in patients with acute SCI. This will be a randomized, double-blind, placebo-controlled trial of IV ZA to prevent bone loss early after SCI. Up to 48 subjects will be randomized to receive a one-time dose of 5 mg of IV ZA versus placebo within 21 days of an SCI. | |||
Detailed Description | Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture prevention and the associated morbidity of bed rest and further secondary complications. Intravenous (IV) zoledronic acid (ZA) has been shown to be more effective than other agents in reducing bone mass resorption and fracture of the legs in post-menopausal women, but has not been studied in acute spinal cord injury. Two previous studies of ZA in persons with subacute SCI, while promising, were inconclusive. As stated in the long range plan of the National Institute on Disability and Rehabilitation Research (NIDRR), one goal in the area of health and function is to "focus on the onset of new conditions…exacerbation of existing conditions, or the development of coexisting conditions." This study is intended to demonstrate reduction in loss of bone mass at the hip and knee regions in acute SCI in a rigorous study of sufficient size to determine effectiveness of our intervention. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Spinal Cord Injury | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
15 | |||
Original Estimated Enrollment ICMJE |
48 | |||
Estimated Study Completion Date ICMJE | March 2021 | |||
Actual Primary Completion Date | March 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01642901 | |||
Other Study ID Numbers ICMJE | 11F.612 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Thomas Jefferson University | |||
Study Sponsor ICMJE | Thomas Jefferson University | |||
Collaborators ICMJE | Department of Health and Human Services | |||
Investigators ICMJE |
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PRS Account | Thomas Jefferson University | |||
Verification Date | September 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |