Denosumab and Osteoporotic Vertebral Compression Fracture

Southern University of Science and Technology

Status and phase

Completed

Phase 3

Phase 2

Conditions

Osteoporotic Vertebral Compression Fracture

Treatments

Drug: Denosumab 60 mg/ml [Prolia]

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05058443

ShenzhenPH spine

Details and patient eligibility

About

This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a 12-month follow-up period.

Full description

We performed a single-center, placebo-controlled, randomized clinical trial in the Department of Spinal Surgery located at the First Affiliated Hospital of Southern University of Science and Technology (Shenzhen People's Hospital). All patients underwent vertebroplasty and randomly received denosumab treatment or placebo control after surgery. The BMDs (lumbar, total hip, and femoral neck) and BTMs were assessed at baseline, 6, and 12 months post-operation. The visual analog scale (VAS) score for back pain, and function status questionnaires, including EuroQol five-dimension (EQ-5D), the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), and the Roland-Morris Disability Functioning Questionnaire (RMDQ),secondary fracture rate, and adverse effects in OVCF patients after vertebroplasty during a 12-month follow-up period.

Enrollment

90 patients

Sex

All

Ages

50 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Must be age between 50 and 90 years old
X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
Bone mineral density T value less than -1 via dual-energy X-ray
A recent fracture history less than 6 weeks
MRI show bone marrow edema of fractured vertebrae
low back pain, local paravertebral tenderness

Exclusion criteria

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 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 open surgery
Must be able to have no other established contraindications for elective surgery