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

March 7, 2011
March 7, 2011
January 2011
December 2011   (final data collection date for primary outcome measure)
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Not Provided
No Changes Posted
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Not Provided
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The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion
The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Image Changes of Lumbar Fusion
  • Bone Turnover Markers
  • Bone Mineral Density
  • Drug: zoledronic acid
    zoledronic acid, 5mg(100ml), intravenous, one time at three days postoperatively
  • Drug: sodium chloride
    sodium chloride, 100ml, intravenous, one time at three days postoperatively
  • Experimental: Experimental group
    Three days postoperatively, patients in this group are given one infusion of zoledronic acid intravenously.
    Intervention: Drug: zoledronic acid
  • Placebo Comparator: Placebo Comparator
    Three days postoperatively, patients in this group are given one infusion of sodium chloride intravenously.
    Intervention: Drug: sodium chloride
Colón-Emeric C, Nordsletten L, Olson S, Major N, Boonen S, Haentjens P, Mesenbrink P, Magaziner J, Adachi J, Lyles KW, Hyldstrup L, Bucci-Rechtweg C, Recknor C; HORIZON Recurrent Fracture Trial. Association between timing of zoledronic acid infusion and hip fracture healing. Osteoporos Int. 2011 Aug;22(8):2329-36. doi: 10.1007/s00198-010-1473-1. Epub 2010 Dec 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
April 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
50 Years to 70 Years
No
Contact: Chao Li, bachelor 15202183944 lichao0457034@gmail.com
China
 
NCT01310465
FudanU-0457034
Yes
Jian Dong, Department of Orthopedics of Zhongshan Hospital of Fudan University,
Fudan University
Not Provided
Not Provided
Fudan University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP