Denosumab vs Zoledronate After Lumbar Fusion
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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 osteopenia or osteoporosis. The trial aims to investigate whether denosumab was non-inferior or superior to zoledronate in osteopenic patients with lumbar fusion surgery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Denosumab denosumab (60 mg subcutaneously, per 6 month) |
Drug: Denosumab 60 MG/ML
60 mg subcutaneously per 6 month
Other Names:
|
| Active Comparator: zoledronate zoledronate (5mg, intravenous infusion once a year) |
Drug: Zoledronate
5mg, intravenous infusion once a year
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Lumbar bone mineral density(BMD) [up to 12 months]
Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dualenergy X-ray
- Total hip BMD [up to 12 months]
Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray
- Femoral neck BMD [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) [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) [up to 12 months]
Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery
- Visual analog scale (VAS) back [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 Outcome Measures
- The Roland-Morris Disability Questionnaire [up to 12 month]
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.
- The QUALEFFO-31 Questionnaire [up to 12 month]
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.
- The EQ-5D Questionnaire [up to 12 month]
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).
- New fracture rate [up to 12 month]
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.
- Complications [up to 12 month]
Complications including cage subsidence, pedicle screw loosening, infection, peripheral nerve injury, and recurrent symptoms were assessed.
- Adverse events [up to 12 month]
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.
Eligibility Criteria
Criteria
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 weekness
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ShenzhenPH | Shenzhen | Guangdong | China | 518000 |
Sponsors and Collaborators
- Shenzhen People's Hospital
Investigators
- Study Chair: Songlin Peng, Doctor, Shenzhen People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ShenzhenPH spine06