Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture

Southern University of Science and Technology

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Denosumab vs Zoledronate

Treatments: Drug: Denosumab; Drug: Zoledronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05106517

ShenzhenPH spine wang04

Details and patient eligibility

About

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

Full description

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.

Enrollment: 122 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 2 patient groups

denosumab

Experimental group

Description:

Denosumab 60mg/6 months subcutaneously + placebo intravenous

Treatment:

Drug: Denosumab

zoledronic acid

Experimental group

Description:

intravenous zoledronic acid and placebo /6 months subcutaneously

Treatment:

Drug: Zoledronic acid