Denosumab Protects Bone Loss and Function in Osteopenia Patients With Lumbar Degenerative Diseases After Lumbar Fusion Surgery, a Randomized, Placebo Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Type 1 n-terminal propeptide P1NP
Study Overview
Brief Summary
Degenerative lumbar spinal diseases have become a common health problem and the most frequent indication for spinal surgery in elderly individuals. It mainly contain lumbar spinal stenosis and spondylolisthesis, occurs in most people over 60 years of age, and patients primarily diagnosed with lumbar degenerative disease are more likely to have osteoporosis. Our study was to explore denosumab effect on bone quality and functional status in osteopenia patients with lumbar degenerative diseases after lumbar fusion surgery.
Detailed Description
However, It was still unknown for denosumab effect on osteopenia patients after lumbar fusion. Bone mineral density(BMD), bone turnover marker, lumbar functional status Roland-Morris Disability Functioning Questionnaire (RMDQ) and quality of life EuroQol Five-Dimension (EQ-5D), and Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) score, rate of new fracture, re-operation, lumbar fusion, complications or adverse events were still unknown. Our study will explore the effect of denosumab on lumbar, total hip, femoral neck BMD and bone turnover markers, functional status EQ-5D, QUALEFFO-31 and RMDQ score of participants after lumbar fusion at 12 months follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants aged 40 to 85 years
- •who diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis
- •osteopenia with BMD T score between -1.0 and -2.5 via dual-energy X-ray
- •low back pain or leg numbness or weakness
- •MRI demonstrated signs of nerve compression
Exclusion Criteria
- •cauda equina syndrome
- •progressive neurologic deficit
- •history of cancer
- •scoliosis greater than 15°
- •back open surgery history
- •have contraindications for surgery
- •who had anti-osteoporosis medication within 6 weeks
Arms & Interventions
Denosumab
Denosumab 60 mg were injected subcutaneously Q6M on the same day after lumbar fusion surgery, and all patients received calcium supplementation 1200 mg/D and vitamin D 800 IU/D.
Intervention: Denosumab (Drug)
Placebo
Equal volume of saline (0.9%) as placebo were injected subcutaneously Q6M on the same day after lumbar fusion surgery, and all patients received calcium supplementation 1200 mg/D and vitamin D 800 IU/D.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Type 1 n-terminal propeptide P1NP
Time Frame: up to 12 months
Bone formation marker, type 1 n-terminal propeptide P1NP were determined at baseline, 6 and 12 months after surgery.
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 months via Dual-energy X-ray.
C-terminal crosslinking type 1 collagen terminal peptide CTX
Time Frame: up to 12 months
Bone resorption marker, C-terminal crosslinked type 1 collagen terminal peptide, CTX were assessed at baseline, 6 and 12 months after surgery.
Visual analog scale (VAS) back
Time Frame: up to 12 months
VAS score for back pain were assessed at baseline, 6 and 12 months. 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.
VAS leg
Time Frame: up to 12 months
VAS score for leg pain were assessed at baseline, 6 and 12 months. 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
- Lumbar Fusion rate(up to 12 month)
- Reoperation rate(up to 12 month)
- Complications(up to 12 month)
- QUALEFFO-31 Questionnaire(up to 12 month)
- EQ-5D quality of life questionnaire(up to 12 month)
- Roland-Morris Disability Questionnaire(up to 12 month)
- New fracture rate(up to 12 month)
- Adverse effect(up to 12 month)