Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
This study is currently recruiting participants.
Verified April 2013 by Northwestern University
Sponsor:
Thomas J. Schnitzer
Collaborator:
Novartis
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier:
NCT00844480
First received: February 13, 2009
Last updated: April 3, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bone Loss |
Drug: zoledronic acid Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss |
Resource links provided by NLM:
Further study details as provided by Northwestern University:
Primary Outcome Measures:
- Bone mass density (BMD) at distal femur [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- BMD at proximal tibia, hip, spine, heel and forearm [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 34 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: zoledronic acid |
Drug: zoledronic acid
zoledronic acid, 5mg, iv
Other Name: Reclast, zoledronic acid
|
| Placebo Comparator: placebo |
Drug: placebo
iv
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women
- Age 18 years and older
- Spinal cord injury within 8 weeks of study entry
- ASIA AIS A or B
- Medically stable in the opinion of their physiatrist
- Able to have dexa performed
- Able to return for follow-up at 6 and 12 months
Exclusion Criteria:
- Vitamin D deficiency
- Hypocalcemia
- Renal insufficiency (estimated creatinine clearance <30ml/min)
- Abnormal thyroid hormone status
- Abnormal mental status
- Osteoporosis at the hip or spine by dexa
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844480
Locations
| United States, Illinois | |
| Rehabilitation Institute of Chicago | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Kristi Herrmann 312-503-1215 k-herrmann@northwestern.edu | |
| Principal Investigator: Thomas J Schnitzer, MD, PhD | |
Sponsors and Collaborators
Thomas J. Schnitzer
Novartis
Investigators
| Principal Investigator: | Thomas J Schnitzer, MD, PhD | Northwestern University |
More Information
No publications provided
| Responsible Party: | Thomas J. Schnitzer, professor, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00844480 History of Changes |
| Other Study ID Numbers: | RIC-TJS003 |
| Study First Received: | February 13, 2009 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Northwestern University:
|
spinal cord injury osteoporosis bone loss zoledronic acid bisphosphonate |
Additional relevant MeSH terms:
|
Bone Diseases, Metabolic Spinal Cord Injuries Bone Diseases Musculoskeletal Diseases Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases |
Trauma, Nervous System Wounds and Injuries Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013