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

Fudan University

Status and phase: Unknown; Phase 4

Conditions: Bone Mineral Density; Bone Turnover Markers; Image Changes of Lumbar Fusion

Treatments: Drug: zoledronic acid; Drug: sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01310465

FudanU-0457034

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

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

Treatment:

Drug: zoledronic acid

Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: sodium chloride