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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01310465
First received: March 7, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Fudan University:

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310465

Contacts
Contact: Chao Li, bachelor 15202183944 lichao0457034@gmail.com

Locations
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         
Sponsors and Collaborators
Fudan University
  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 July 20, 2014