Zoledronic Acid in Acute Spinal Cord Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01642901|
Recruitment Status : Active, not recruiting
First Posted : July 17, 2012
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Drug: Zoledronic acid Drug: normal saline 0.9%||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Zoledronic Acid to Prevent Bone Loss After Acute Spinal Cord Injury|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: Zoledronic Acid 5 mg IV infusion
Single infusion of 5 mg intravenous zoledronic acid given within 21 days of acute traumatic spinal cord injury.
Drug: Zoledronic acid
5 mg zoledronic acid infused intravenously over two hours (2.5mg per hour), given only once, within 21 days of acute traumatic spinal cord injury.
Other Name: Reclast
Placebo Comparator: normal saline 0.9%
Infusion of normal saline of equivalent volume to reconstituted zoledronic acid, given only once and run over 2 hours, to occur within 21 days of acute traumatic spinal cord injury.
Drug: normal saline 0.9%
Infusion of equivalent volume of 0.9% normal saline to that of the reconstituted zoledronic acid, given only once over two hours, occurring within 21 days of acute traumatic spinal cord injury
- 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.
- Biomarkers of bone formation and resorption [ Time Frame: Baseline, 1 month, 4 month, and 12 months ]
Collection of blood biomarkers of bone formation and resorption at selected time intervals within the first 12 months post-injury.
This will observe the timing of metabolic indexes of bone formation and resorption, and of pro-osteoclastogenic factors promoting bone resorption.
- safety and tolerability of zoledronic acid [ Time Frame: one year ]Assessment of the safety and tolerability of zoledronic acid in the acute spinal cord injury population. This will be done by examination reportable adverse events including fevers, flu-like symptoms, GI upset as measures of safety and report of patient's willingness to have participate in physical therapy in the first week after receiving medication as a measure of tolerability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642901
|United States, Pennsylvania|
|Thomas Jefferson University and Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Christina V Oleson, MD||Thomas Jefferson University|