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Denosumab and Osteoporotic Vertebral Compression Fracture

NCT05058443 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-02-21

No results posted yet for this study

Summary

This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a 12-month follow-up period.

Conditions

  • Osteoporotic Vertebral Compression Fracture

Interventions

DRUG

Denosumab 60 mg/ml [Prolia]

denosumab subcutaneously every 6 months (Q6M)

DRUG

Placebo

placebo subcutaneously every 6 months (Q6M)

Sponsors & Collaborators

  • Shenzhen People's Hospital

    lead OTHER

Principal Investigators

  • Xiao Xiao, Doctor · Shenzhen People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-06
Primary Completion
2022-08-05
Completion
2022-08-10

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05058443 on ClinicalTrials.gov