Denosumab vs Zoledronate After Lumbar Fusion

Study Overview
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Brief Summary
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The aim of the study was to compare denosumab and zoledronate efficacy in bone mass, bone turnover markers (BTMs), Visual Analogue Scale (VAS) for leg and back, EuroQol Five-Dimension (EQ-5D) scores, Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) scores, and Roland-Morris Disability Functioning Questionnaire (RMDQ) scores, secondary fracture, complications and adverse events after lumbar fusion.

Detailed Description
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Lumbar degenerative disease including spinal stenosis and lumbar spondylolisthesis were the most common reason lead to older patients disability, which was the main indication for older patients to perform lumbar fusion surgery. For patients with lumbar degenerative disease older than 50 years old, a proportion of patients had osteoporosis. The trial aims to investigate whether denosumab versus zoledronate acid in osteopenic patients with lumbar fusion surgery.

Official Title
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Denosumab vs Zoledronate Efficacy in Osteopenic Patients With Lumbar Degenerative Disease After Lumbar Fusion Surgery

Conditions
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Osteopenia, Lumbar Spondylolisthesis

Intervention / Treatment
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* Drug: Denosumab 60 mg/ml [Prolia]
* Drug: Zoledronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants aged 40 to 85 years who diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis osteopenia with BMD T score between -1 and -2.5 via dual energy X-ray low back pain or leg numbness or weakness MRI demonstrated signs of nerve compression patients with one or two level symptoms. 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Denosumab<br>denosumab (60 mg subcutaneously, per 6 month) | Drug: Denosumab 60 mg/ml [Prolia]<br>* 60 mg subcutaneously per 6 month<br>* Other names: Denosumab 6 month/subcutaneous;|
| Active Comparator: zoledronate<br>zoledronate (5mg, intravenous infusion once a year) | Drug: Zoledronate<br>* 5mg, intravenous infusion once a year<br>* Other names: Zoledronic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar bone mineral density(BMD) | Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual energy X-ray | up to 12 months | 
| Total hip BMD | Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray | up to 12 months | 
| Femoral neck BMD | Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray | up to 12 months | 
| Procollagen type 1 n-terminal propeptide (P1NP) | Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery | up to 12 months | 
| C-terminal cross-linked type 1 collagen terminal peptide (CTX) | Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery | up to 12 months | 
| Visual analog scale (VAS) back | 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. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Roland-Morris Disability Questionnaire | The Roland-Morris Disability Questionnaire is scored by 24 adding up the number of items checked yes on different low back pain-related daily activity disabilities. Total scores range from 0 to 24, with higher scores 24 indicating a higher level of disability related to low back pain and lowest 0 represents no back pain. | up to 12 month | 
| The QUALEFFO-31 Questionnaire | The Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), which contains three domains including pain, physical function, and mental function. This scale is assessed on a scale of 0 to 100, with 0 indicating the highest QoL and 100 the lowest. | up to 12 month | 
| The EQ-5D Questionnaire | The EuroQol five-dimension (EQ-5D) questionnaire evaluates health status consisting five dimensions: mobility, selfcare, performance of usual activities, pain or discomfort, and anxiety or depression. After conversion, the index was between 0 and 1.0 (minimum score: 0, indicating worst health state; full score:1.0, indicating full health). | up to 12 month | 
| New fracture rate | New fracture rate containing vertebral fracture and non-vertebral fracture was assessed at 12 month after surgery. The lowest score was 0, the highest score was 100%. The lower score 0 represents no secondary fracture. | up to 12 month | 
| Complications | Complications including cage subsidence, pedicle screw loosening, infection, peripheral nerve injury, and recurrent symptoms were assessed. | up to 12 month | 
| Adverse events | The main adverse events including deep venous thrombosis, pneumonia, acute renal failure, pulmonary embolism, myocardial infarction, influenza, transfer to intensive care unit, joint pain, headache, nausea, osteonecrosis of the jaw, atypical femoral fracture and rash. | up to 12 month |