Denosumab and Screw Fixation for Osteoporotic Compression Fracture

Southern University of Science and Technology

Status and phase

Withdrawn

Phase 3

Phase 2

Conditions

Denosumab Allergy

Treatments

Drug: Denosumab Only Product

Study type

Interventional

Funder types

Other

Identifiers

NCT05065164

ShenzhenPH spine wang02

Details and patient eligibility

About

Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: 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 were compared 1 year after screw internal fixation of osteoporotic vertebral compression fracture (OVCF) with desomumab versus placebo in Shenzhen People's Hospital from September, 2021 to September, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed

Sex

All

Ages

40 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:• Must be age between 40 and 90 years old

X-ray diagnosis of 1-2 vertebral compression fractures
Dual energy X ray test bone mineral density T value less than -1
fracture history lasted within 6 weeks
MRI showed bone marrow edema of injured segment
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 previous use of anti-osteoporosis drugs within 6 weeks
- 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