The Effect of Zoledronic Acid to Bone Fusion & Bone NCT01310465

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number	NCT01310465
Other study ID #	FudanU-0457034
Secondary ID
Status	Recruiting
Phase	Phase 4
First received	March 7, 2011
Last updated	March 7, 2011
Start date	January 2011
Est. completion date	April 2012

Study information
Verified date	January 2011
Source	Fudan University
Contact	Chao Li, bachelor
Phone	15202183944
Email	lichao0457034[@]gmail.com
Is FDA regulated	No
Health authority	China: Food and Drug Administration
Study type	Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status	Recruiting
Enrollment	50
Est. completion date	April 2012
Est. primary completion date	December 2011
Accepts healthy volunteers	No
Gender	Both
Age group	50 Years to 70 Years
Eligibility	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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• zoledronic acid
zoledronic acid, 5mg(100ml), intravenous, one time at three days postoperatively
• sodium chloride
sodium chloride, 100ml, intravenous, one time at three days postoperatively

Locations
Country	Name	City	State
China	Zhongshan hospital of Fudan university	Shanghai	Shanghai

Sponsors *(1)*
Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China,

References & Publications (1)

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. — View Citation

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External Links

Zhongshan Hospital

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

Clinical Trial Details — Status: Recruiting

Administrative data

Study information