Denosumab Protects Bone Loss and Function in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: a Randomized Placebo-controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Lumbar bone mineral density(BMD)
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Denosumab
Denosumab 60 mg were injected subcutaneously every 6 months (Q6M)
Intervention: Denosumab 60 mg/ml [Prolia] (Drug)
Placebo
Equal volume of saline (0.9%) as placebo were injected subcutaneously every 6 months (Q6M)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Lumbar bone mineral density(BMD)
Time Frame: up to 12 months
Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.
Total hip BMD
Time Frame: up to 12 months
Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.
Femoral neck BMD
Time Frame: up to 12 months
Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray
Visual analog scale (VAS) back
Time Frame: up to 12 months
The VAS score for back pain were determined at baseline, 6 and 12 month. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.
Procollagen type 1 n-terminal propeptide (P1NP)
Time Frame: up to 12 months
Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery.
C-terminal cross-linked type 1 collagen terminal peptide (CTX)
Time Frame: up to 12 months
Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery
Secondary Outcomes
- The QUALEFFO-31 Questionnaire(up to 12 month)
- The EQ-5D Questionnaire(up to 12 month)
- Secondary fracture rate(up to 12 month)
- Adverse events(up to 12 month)
- The Roland-Morris Disability Questionnaire(up to 12 month)