Clinical trial NCT05058443: Denosumab and Osteoporotic Vertebral Compression Fracture
Official title: Denosumab Protects Bone Loss and Function in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: a Randomized Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Osteoporotic Vertebral Compression Fracture
Keywords: denosumab
vertebroplasty
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a 12-month follow-up period.

Detailed description: We performed a single-center, placebo-controlled, randomized clinical trial in the Department of Spinal Surgery located at the First Affiliated Hospital of Southern University of Science and Technology (Shenzhen People's Hospital). All patients underwent vertebroplasty and randomly received denosumab treatment or placebo control after surgery. The BMDs (lumbar, total hip, and femoral neck) and BTMs were assessed at baseline, 6, and 12 months post-operation. The visual analog scale (VAS) score for back pain, and function status questionnaires, including EuroQol five-dimension (EQ-5D), the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), and the Roland-Morris Disability Functioning Questionnaire (RMDQ),secondary fracture rate, and adverse effects in OVCF patients after vertebroplasty during a 12-month follow-up period.

Eligibility criteria: Inclusion Criteria:

* Must be age between 50 and 90 years old
* X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
* Bone mineral density T value less than -1 via dual-energy X-ray
* A recent fracture history less than 6 weeks
* MRI show bone marrow edema of fractured vertebrae
* low back pain, local paravertebral tenderness

Exclusion Criteria:

* Must be able to have no intervertebral fissure
* Must be able to have no infection
* Must be able to have no malignancy
* Must be able to have no neurological dysfunction
* Must be able to have no previous use of anti-osteoporosis drugs
* Must be able to have no inability to perform magnetic resonance imaging
* Must be able to have no prior back open surgery
* Must be able to have no other established contraindications for elective surgery

Primary outcomes:
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: 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: 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: Secondary fracture rate
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: Xiao Xiao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang R, Qian X, Xuan Z, Xu Y, Chen Y, Gu H, Fu C. Health related quality of life and its impacts by chronic diseases in urban community population, Shanghai, China in 2015. Psychol Health Med. 2021 Sep;26(8):931-939. doi: 10.1080/13548506.2020.1856896. Epub 2020 Dec 11.
citation: Zhou C, Li Q, Huang S, Fan L, Wang B, Dai J, Tang X. Validation of the simplified Chinese version of the quality of life questionnaire of the European foundation for osteoporosis (QUALEFFO-31). Eur Spine J. 2016 Jan;25(1):318-324. doi: 10.1007/s00586-015-4066-z. Epub 2015 Jun 14.
citation: Stevens ML, Lin CC, Maher CG. The Roland Morris Disability Questionnaire. J Physiother. 2016 Apr;62(2):116. doi: 10.1016/j.jphys.2015.10.003. Epub 2015 Dec 11. No abstract available.