Desomumab vs Zoledronic Acid and Osteoporotic Compression Fracture

• Status: Recruiting
• Trial end date: 2022-10-11
• Target enrollment: 0
• Participant gender: All

Summary

Bone mineral density and function at 1 year after screw fixation with desomumab vs zoldronic acid for osteoporotic vertebral compression fractures: 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; Zoledronic Acid

Criteria

Inclusion Criteria:

• Must be age between 40 and 90 years old

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

• DEXA test BMD T value was 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