Denosumab Effect on Bone Quality and Function After Lumbar Fusion Surgery

Southern University of Science and Technology

Status: Completed

Conditions: Osteopenia; Spine Fusion; Denosumab Allergy

Treatments: Drug: Denosumab; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05415657

ShenzhenPH spine01

Details and patient eligibility

About

Degenerative lumbar spinal diseases have become a common health problem and the most frequent indication for spinal surgery in elderly individuals. It mainly contain lumbar spinal stenosis and spondylolisthesis, occurs in most people over 60 years of age, and patients primarily diagnosed with lumbar degenerative disease are more likely to have osteoporosis. Our study was to explore denosumab effect on bone quality and functional status in osteopenia patients with lumbar degenerative diseases after lumbar fusion surgery.

Full description

However, It was still unknown for denosumab effect on osteopenia patients after lumbar fusion. Bone mineral density(BMD), bone turnover marker, lumbar functional status Roland-Morris Disability Functioning Questionnaire (RMDQ) and quality of life EuroQol Five-Dimension (EQ-5D), and Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) score, rate of new fracture, re-operation, lumbar fusion, complications or adverse events were still unknown. Our study will explore the effect of denosumab on lumbar, total hip, femoral neck BMD and bone turnover markers, functional status EQ-5D, QUALEFFO-31 and RMDQ score of participants after lumbar fusion at 12 months follow-up.

Enrollment: 76 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 -1.0 and -2.5 via dual-energy X-ray
• low back pain or leg numbness or weakness
• MRI demonstrated signs of nerve compression

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: Triple Blind

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76 participants in 2 patient groups, including a placebo group

Denosumab

Experimental group

Description:

Denosumab 60 mg were injected subcutaneously Q6M on the same day after lumbar fusion surgery, and all patients received calcium supplementation 1200 mg/D and vitamin D 800 IU/D.

Treatment:

Drug: Denosumab

Placebo

Placebo Comparator group

Description:

Equal volume of saline (0.9%) as placebo were injected subcutaneously Q6M on the same day after lumbar fusion surgery, and all patients received calcium supplementation 1200 mg/D and vitamin D 800 IU/D.

Treatment:

Drug: Placebo