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Denosumab vs Alendronate After Vertebroplasty

NCT05662358 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-02-21

No results posted yet for this study

Summary

Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and alendronate is both effective to prevent bone loss for OVCF postmenopausal women. However, trial evidence comparing effect of denosumab vs zoledronate after PVP was unknown. The study aims to assess the efficiency of denosumab vs alendronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP

Conditions

  • Denosumab Allergy

Interventions

DRUG

Denosumab

1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection

DRUG

Alendronate

oral 70 mg alendronate sodium weekly plus subcutaneous placebo per 6 month.

DRUG

Placebo

oral placebo weekly

Sponsors & Collaborators

  • Shenzhen People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-03
Primary Completion
2023-09-20
Completion
2023-10-25

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 NCT05662358 on ClinicalTrials.gov