Denosumab vs Alendronate in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Total hip BMD
Study Overview
Brief Summary
Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and alendronate is both effective to prevent bone loss for OVCF postmenopausal women. However, trial evidence comparing effect of denosumab vs zoledronate after PVP was unknown. The study aims to assess the efficiency of denosumab vs alendronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP
Detailed Description
Whether denosumab was non-inferior than alendronate in improving bone mineral density (BMD), bone turnover markers (BTMs), functional status questionnaires, and secondary fracture in elderly patients with OVCF after PVP remains unknown. A prospective, randomized, placebo-controlled clinical trial in OVCF patients with PVP was performed. This study aimed to investigate the efficiency of denosumab vs alendronate on BMD, BTMs, functional status, secondary fracture rate, and adverse events in OVCF patients after PVP 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 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Must be age between 50 and 85 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
alendronate
oral 70 mg alendronate sodium weekly.
Intervention: Placebo (Drug)
Denosumab
1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months
Intervention: Placebo (Drug)
Denosumab
1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months
Intervention: Denosumab (Drug)
alendronate
oral 70 mg alendronate sodium weekly.
Intervention: Alendronate (Drug)
Outcomes
Primary Outcomes
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.
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
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
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
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
Secondary Outcomes
- Secondary fracture rate(up to 12 month)
- The Roland-Morris Disability Questionnaire(up to 12 month)
- Adverse events(up to 12 month)
- The EQ-5D Questionnaire(up to 12 month)
- The QUALEFFO-31 Questionnaire(up to 12 month)