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

NCT01310465 | Unknown Phase 4 DMC

• 1 other identifier: FudanU-0457034
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Image Changes of Lumbar Fusion; Bone Turnover Markers; Bone Mineral Density

Study Arms (2)

Experimental group

EXPERIMENTAL

Three days postoperatively, patients in this group are given one infusion of zoledronic acid intravenously.

Drug: zoledronic acid

Placebo Comparator

PLACEBO COMPARATOR

Three days postoperatively, patients in this group are given one infusion of sodium chloride intravenously.

Drug: sodium chloride

Interventions

zoledronic acid DRUG

zoledronic acid, 5mg(100ml), intravenous, one time at three days postoperatively

Experimental group

sodium chloride DRUG

sodium chloride, 100ml, intravenous, one time at three days postoperatively

Placebo Comparator

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with lumbar degenerative disease who have had lumbar interbody fusion surgery
• Age 50-70 years old
• Willing to sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan hospital of Fudan university

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Colon-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.

  PMID: 21153021 BACKGROUND

MeSH Terms

Interventions

Zoledronic Acid; Sodium Chloride

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Chao Li, bachelor

CONTACT

15202183944; lichao0457034@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 8, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: March 8, 2011

Record last verified: 2011-01

Locations

CN (1)