Clinical trial NCT05415657: Denosumab Effect on Bone Quality and Function After Lumbar Fusion Surgery
Official title: Denosumab Protects Bone Loss and Function in Osteopenia Patients With Lumbar Degenerative Diseases After Lumbar Fusion Surgery, a Randomized, Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Spine Fusion
Denosumab Allergy
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 76
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: 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.

Detailed 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.

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 -1.0 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

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: Type 1 n-terminal propeptide P1NP
timeFrame: up to 12 months
measure: C-terminal crosslinking type 1 collagen terminal peptide CTX
timeFrame: up to 12 months
measure: Visual analog scale (VAS) back
timeFrame: up to 12 months
measure: VAS leg
timeFrame: up to 12 months
Secondary outcomes:
measure: EQ-5D quality of life questionnaire
timeFrame: up to 12 month
measure: Roland-Morris Disability Questionnaire
timeFrame: up to 12 month
measure: QUALEFFO-31 Questionnaire
timeFrame: up to 12 month
measure: Lumbar Fusion rate
timeFrame: up to 12 month
measure: New fracture rate
timeFrame: up to 12 month
measure: Reoperation rate
timeFrame: up to 12 month
measure: Complications
timeFrame: up to 12 month
measure: Adverse effect
timeFrame: up to 12 month
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: ShenzhenPH
state: Guangdong
Study officials:
References: