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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01310465
Enrollment
50
Registered
2011-03-08
Start date
2011-01-31
Completion date
2012-04-30
Last updated
2011-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGzoledronic acid

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

DRUGsodium chloride

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

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
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

Countries

China

Contacts

Primary ContactChao Li, bachelor
lichao0457034@gmail.com15202183944

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026