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

Phase 2TerminatedNCT00844480

Thomas J. Schnitzer17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Bone Loss

Interventions

zoledronic acidDRUG

zoledronic acid, 5mg, iv

placeboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Bone Mass Density (BMD) at Total Hip

bone mineral density measured by DXA at the total hip

Time frame: 6 months

Secondary Outcomes

BMD at Other Skeletal Sites

BMD at spine, femoral neck, distal femur, proximal tibia, heel

Time frame: 6 months

Data from ClinicalTrials.gov

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