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NCT00844480 Clinical Trial

Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss

Bone Loss Clinical Trial

Official title:
Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00844480
Other study ID # RIC-TJS003
Secondary ID
Status Terminated
Phase Phase 2
First received February 13, 2009
Last updated May 6, 2016
Start date March 2010
Est. completion date January 2016

Study information
Verified date May 2016
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 17
Est. completion date January 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Men and women

2. Age 18 years and older

3. Spinal cord injury within 8 weeks of study entry

4. ASIA AIS A or B

5. Medically stable in the opinion of their physiatrist

6. Able to have dexa performed

7. Able to return for follow-up at 6 and 12 months

Exclusion Criteria:

1. Vitamin D deficiency

2. Hypocalcemia

3. Renal insufficiency (estimated creatinine clearance <30ml/min)

4. Abnormal thyroid hormone status

5. Abnormal mental status

6. Osteoporosis at the hip or spine by dexa

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• zoledronic acid
zoledronic acid, 5mg, iv
• placebo
iv

Locations
Country Name City State
United States Rehabilitation Institute of Chicago Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Thomas J. Schnitzer Novartis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bone mass density (BMD) at distal femur 3,6, and 12 months No
Secondary BMD at proximal tibia, hip, spine, heel and forearm 3,6, and 12 months No
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