The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Image Changes of Lumbar Fusion Bone Turnover Markers Bone Mineral Density |
Drug: zoledronic acid Drug: sodium chloride |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion |
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental group
Three days postoperatively, patients in this group are given one infusion of zoledronic acid intravenously.
|
Drug: zoledronic acid
zoledronic acid, 5mg(100ml), intravenous, one time at three days postoperatively
|
|
Placebo Comparator: Placebo Comparator
Three days postoperatively, patients in this group are given one infusion of sodium chloride intravenously.
|
Drug: sodium chloride
sodium chloride, 100ml, intravenous, one time at three days postoperatively
|
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Chao Li, bachelor | 15202183944 | lichao0457034@gmail.com |
| China, Shanghai | |
| Zhongshan hospital of Fudan university | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Chao Li, bachlor 15202183944 lichao0457034@gmail.com | |
| Principal Investigator: Chao Li, bachlor | |
More Information
Additional Information:
Publications:
| Responsible Party: | Jian Dong, Department of Orthopedics of Zhongshan Hospital of Fudan University, |
| ClinicalTrials.gov Identifier: | NCT01310465 History of Changes |
| Other Study ID Numbers: | FudanU-0457034 |
| Study First Received: | March 7, 2011 |
| Last Updated: | March 7, 2011 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013