Denosumab vs Zoledronate After Lumbar Fusion

Phase 3

Recruiting

• Conditions: Lumbar Spondylolisthesis; Osteopenia
• Interventions: Drug: Denosumab 60 mg/ml [Prolia]; Drug: Zoledronate

• Registration Number: NCT05638399
• Lead Sponsor: Shenzhen People's Hospital

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.

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 osteoporosis. The trial aims to investigate whether denosumab versus zoledronate acid in osteopenic patients with lumbar fusion surgery.

Study Timeline

• Study Start: 2020-01-15
• Study First Submitted: 2022-11-25
• Study First Submitted QC: 2022-11-25
• Study First Posted: 2022-12-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-02-26
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab	Denosumab 60 mg/ml [Prolia]	denosumab (60 mg subcutaneously, per 6 month)
zoledronate	Zoledronate	zoledronate (5mg, intravenous infusion once a year)

Primary Outcome Measures

Name	Time	Method
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.
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
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
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
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 dual energy X-ray

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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).

Trial Locations

Locations (1)

ShenzhenPH; 🇨🇳 Shenzhen, Guangdong, China