The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-04-30

Brief Summary

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Many patients who have lumbar degenerative disease suffer from osteoporosis or reduced bone mass or low bone mineral density. Among patients with lumbar degenerative disease, some need fusion surgery. But conditions of osteoporosis or low bone mineral density slow down the rate of bone fusion, reduce the success of bone fusion, and ultimately affect the overall effectiveness of surgery. Zoledronic acid is an effective anti-osteoporotic. Many researchers dispute if zoledronic acid can promote the healing of long bone fractures. But few researchers focus on the effect of zoledronic acid to lumbar fusion. In this study, we select patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. Three days postoperatively, the patients were randomized to either one infusion of zoledronic acid or sodium chloride intravenously. We follow all these patients for 6 months. During this time, we detect bone metabolism and bone fusion of these patients. At last, we can tell if zoledronic acid can modify bone metabolism and promote bone fusion.

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Detailed Description

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Conditions

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Image Changes of Lumbar Fusion Bone Turnover Markers Bone Mineral Density

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group

Three days postoperatively, patients in this group are given one infusion of zoledronic acid intravenously.

Group Type EXPERIMENTAL

zoledronic acid

Intervention Type DRUG

zoledronic acid, 5mg(100ml), intravenous, one time at three days postoperatively

Placebo Comparator

Three days postoperatively, patients in this group are given one infusion of sodium chloride intravenously.

Group Type PLACEBO_COMPARATOR

sodium chloride

Intervention Type DRUG

sodium chloride, 100ml, intravenous, one time at three days postoperatively

Interventions

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zoledronic acid

zoledronic acid, 5mg(100ml), intravenous, one time at three days postoperatively

Intervention Type DRUG

sodium chloride

sodium chloride, 100ml, intravenous, one time at three days postoperatively

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with lumbar degenerative disease who have had lumbar interbody fusion surgery
* Age 50-70 years old
* Willing to sign informed consent

Exclusion Criteria

* Application of strontium ranelate, sodium fluoride or parathyroid hormone
* Application of bisphosphonates more than 8 weeks during 2 years preoperatively
* Suffering from bone fracture during 3 months preoperatively
* Urinary creatinine clearance rate less than 35mL/min
* Serum calcium concentrations greater than 2.75mmol/L or less than 2.00mmol/L
* Pregnancy or breast-feeding women
* Suffering from cancer or other diseases that may be expected to live less than a year

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No