Clinical trial NCT05638399: Denosumab vs Zoledronate After Lumbar Fusion
Official title: Denosumab vs Zoledronate Efficacy in Osteopenic Patients With Lumbar Degenerative Disease After Lumbar Fusion Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteopenia
Lumbar Spondylolisthesis
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: Lumbar bone mineral density(BMD)
timeFrame: up to 12 months
measure: Total hip BMD
timeFrame: up to 12 months
measure: Femoral neck BMD
timeFrame: up to 12 months
measure: Procollagen type 1 n-terminal propeptide (P1NP)
timeFrame: up to 12 months
measure: C-terminal cross-linked type 1 collagen terminal peptide (CTX)
timeFrame: up to 12 months
measure: Visual analog scale (VAS) back
timeFrame: up to 12 months
Secondary outcomes:
measure: The Roland-Morris Disability Questionnaire
timeFrame: up to 12 month
measure: The QUALEFFO-31 Questionnaire
timeFrame: up to 12 month
measure: The EQ-5D Questionnaire
timeFrame: up to 12 month
measure: New fracture rate
timeFrame: up to 12 month
measure: Complications
timeFrame: up to 12 month
measure: Adverse events
timeFrame: up to 12 month
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: ShenzhenPH
state: Guangdong
Study officials:
affiliation: Shenzhen People's Hospital
name: Songlin Peng, Doctor
role: STUDY_CHAIR
References: