Denosumab vs Zoledronate After Lumbar Fusion

Southern University of Science and Technology

Status and phase: Enrolling; Phase 3

Conditions: Osteopenia; Lumbar Spondylolisthesis

Treatments: Drug: Zoledronate; Drug: Denosumab 60 mg/ml [Prolia]

Study type: Interventional

Funder types: Other

Identifiers

NCT05638399

ShenzhenPH spine06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Denosumab

Experimental group

Description:

denosumab (60 mg subcutaneously, per 6 month)

Treatment:

Drug: Denosumab 60 mg/ml [Prolia]

zoledronate

Active Comparator group

Description:

zoledronate (5mg, intravenous infusion once a year)

Treatment:

Drug: Zoledronate