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

Study Overview
=================
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.

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

Conditions
-----------------
Image Changes of Lumbar Fusion, Bone Turnover Markers, Bone Mineral Density

Intervention / Treatment
-----------------
* Drug: zoledronic acid
* Drug: sodium chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Three days postoperatively, patients in this group are given one infusion of zoledronic acid intravenously. | Drug: zoledronic acid<br>* zoledronic acid, 5mg(100ml), intravenous, one time at three days postoperatively<br>|
| Placebo Comparator: Placebo Comparator<br>Three days postoperatively, patients in this group are given one infusion of sodium chloride intravenously. | Drug: sodium chloride<br>* sodium chloride, 100ml, intravenous, one time at three days postoperatively<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |