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

Phase 4

• Conditions: Image Changes of Lumbar Fusion; Bone Turnover Markers; Bone Mineral Density
• Interventions: Drug: zoledronic acid; Drug: sodium chloride

• Registration Number: NCT01310465
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-01
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-07
• Last Update Submitted: 2011-03-07
• Study First Posted: 2011-03-08
• Last Update Posted: 2011-03-08
• Primary Completion: 2011-12
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	zoledronic acid	Three days postoperatively, patients in this group are given one infusion of zoledronic acid intravenously.
Placebo Comparator	sodium chloride	Three days postoperatively, patients in this group are given one infusion of sodium chloride intravenously.

Trial Locations

Locations (1)

Zhongshan hospital of Fudan university; 🇨🇳 Shanghai, Shanghai, China