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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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zoledronic acid

Group Type EXPERIMENTAL

zoledronic acid

Intervention Type DRUG

zoledronic acid, 5mg, iv

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

iv

Interventions

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zoledronic acid

zoledronic acid, 5mg, iv

Intervention Type DRUG

placebo

iv

Intervention Type DRUG

Other Intervention Names

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Reclast, zoledronic acid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No