MedTrace Logo

Effects of Denosumab on Bone Fusion in Osteoporotic Patients After Lumbar Fusion

NCT05203588 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2022-01-24

No results posted yet for this study

Summary

Lumbar fusion is an accepted and effective technique for the treatment of lumbar degenerative disease. As the population ages, disability associated with spinal pathology and spinal surgery is rapidly increasing and there is a concomitant increase in prevalence of osteoporosis which is a detrimental factor for Lumbar fusion and instrumentation. Osteoporosis-related bone fragility is a primary reason for spinal fusion failure, implant fixation failure, and vertebral compression fractures above or below the fusion sites.

Denosumab is a human monoclonal antibody against RANKL, it inhibits osteoclast mediated bone destruction and has been found to be effective in treating osteoporosis, including reducing bone turnover markers, increasing bone mineral density (BMD), and reducing fractures. But few studies focus on the effects of Denosumab on lumbar fusion. In this study, we include osteoporotic patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. The patients were randomized to either treatment of Denosumab or no treatment. All these patients are followed at 3, 6, 9, 12 months postoperation. During these periods, we detect bone metabolism and bone fusion of these patients. Finally, we would report whether Denosumab can improve bone metabolism and promote bone fusion or not.

Conditions

Interventions

DRUG

Denosumab 60 mg/ml Injectable Solution [Prolia]

Denosumab, 60mg(1ml), subcutaneously, totally two times, with one time at 1-week postoperatively and another time at 26-week postoperatively.

DRUG

calcium and vitamin D

calcium (≥1·0 g) and vitamin D (≥400 IU).

Sponsors & Collaborators

  • Shanghai Changzheng Hospital

    lead OTHER

Principal Investigators

  • Changgui Shi, M.D. · Shanghai changzheng hospital, Naval Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-09
Primary Completion
2022-10-31
Completion
2023-10-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05203588 on ClinicalTrials.gov