Denosumab and Osteoporotic Vertebral Compression Fracture

• Status: Recruiting
• Trial end date: 2022-09-25
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of bone mineral density and function at 1 year after vertebral kyphoplasty for osteoporotic vertebral compression fractures with desomumab intervention: a parallel double-blind randomized controlled clinical trial

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shenzhen People's Hospital
• Treatments: Denosumab

Criteria

Inclusion Criteria:

• • Must be age between 40 and 90 years old

• X-ray diagnosis of 1-2 vertebral compression fractures

• DEXA detected BMD T value less than -1

• fracture history lasted within 6 weeks

• MRI showed bone marrow edema of injured segment

• Lower back pain, local spinous tenderness

Exclusion Criteria:

• • Must be able to have no posterior vertebral wall fracture

• Must be able to have no 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 calcium level less than 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