Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture

NCT ID: NCT05106517

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-08

Study Completion Date

2023-03-11

Brief Summary

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Bone mineral density and function at 1 year after screw fixation with denosumab vs zoledronic acid for osteoporotic vertebral compression fractures: a parallel double-blind randomized controlled clinical trial

Detailed Description

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Conduct a single-center, double-blind, randomized controlled clinical trial according to clinical Trial Reporting Standards (CONSORT). Bone mineral density and function of osteoporotic vertebral compression fracture (OVCF) were compared 1 year after screw internal fixation with denosumab vs zoledronic acid in Shenzhen People's Hospital from September, 2021 to November, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed.

Conditions

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Denosumab vs Zoledronate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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denosumab

Denosumab 60mg/6 months subcutaneously + placebo intravenous

Group Type EXPERIMENTAL

Denosumab

Intervention Type DRUG

Denosumab 60mg/6 months subcutaneously + placebo iv

zoledronic acid

intravenous zoledronic acid and placebo /6 months subcutaneously

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Iv zoledronic acid and placebo /6 months subcutaneously

Interventions

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Denosumab

Denosumab 60mg/6 months subcutaneously + placebo iv

Intervention Type DRUG

Zoledronic acid

Iv zoledronic acid and placebo /6 months subcutaneously

Intervention Type DRUG

Other Intervention Names

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Denosumab 6 month/subcutaneous Zoledronic acid intravenous once a year

Eligibility Criteria

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Inclusion Criteria

* Must be age between 40 and 90 years old
* X-ray diagnosis of 1-2 vertebral compression fractures
* Dual eneragy X ray test for bone mineral density T value less than -1
* fracture history lasted within 6 weeks
* Must be MRI showed bone marrow edema of injured segment
* Must be lower back pain, local spines tenderness

Exclusion Criteria

* Must be able to have no posterior vertebral wall fracture
* Must be able to have no patients with intervertebral fissure
* Must be able to have no infection
* Must be able to have no malignancy
* Must be able to have no neurological dysfunction
* Must be able to have no calcium level ≤2.13 mmol/L
* Must be able to have no previous use of anti-osteoporosis drugs
* Must be able to have no inability to perform magnetic resonance imaging
* Must be able to have no prior back surgery
* Must be able to have no other established contraindications for elective surgery
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shenzhen People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ShenzhenPH

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongyu Wang, Doctor

Role: CONTACT

18241651300

Facility Contacts

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Hongyu Wang, Doctor

Role: primary

18241651300

Other Identifiers

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ShenzhenPH spine wang04

Identifier Type: -

Identifier Source: org_study_id

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