Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: a parallel double-blind randomized controlled clinical trial
Conduct a single-center, double-blind, randomized controlled clinical trial according to clinical Trial Reporting Standards (CONSORT). Bone mineral density and function were compared 1 year after screw internal fixation of osteoporotic vertebral compression fracture (OVCF) with desomumab versus placebo in Shenzhen People's Hospital from September, 2021 to September, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
denosumab subcutaneous injection /6 months, twice a year
ShenzhenPH
Shenzhen, Guangdong, China
age
participants age (year)
Time frame: up to 12 months
sex
participants sex
Time frame: up to 12 months
height
participants height cm
Time frame: up to 12 months
weight
participants weight kg
Time frame: up to 12 months
BMI
participants body mass index
Time frame: up to 12 months
osteocalcin
osteocalcin in the N terminal molecular fragment
Time frame: up to 12 months
Procollagen type 1 n-terminal propeptide P1NP
Procollagen type 1 n-terminal propeptide
Time frame: up to 12 months
C-terminal cross-linked type 1 collagen terminal peptide CTX
C-terminal cross-linked type 1 collagen terminal peptide
Time frame: up to 12 months
Serum total calcium
Serum total calcium level
Time frame: up to 12 months
parathyroid hormone
serum parathyroid hormone level
Time frame: up to 12 months
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albumin
serum albumin level
Time frame: up to 12 months
lumber spine bone mineral density
Dual energy X-ray for lumber spine bone mineral density
Time frame: up to 12 months
Hip bone mineral density
Dual energy X-ray for hip bone mineral density
Time frame: up to 12 months
MRI of lumber
Bone marrow edema and adjacent intervertebral disc were detected by MRI
Time frame: up to 12 months
pain visual analogue scores (VAS)
pain visual analogue scores (VAS) use categories to differentiate pain intensity, with 0 being "painless" and 100 being "the worst pain imaginable".
Time frame: up to 12 months
The Roland-Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire is a health status measure designed to be completed by patients to assess physical disability due to low back pain.
Time frame: up to 12 month
QUALEFFO 31
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) was developed in 1997 to evaluate quality of life for patients with osteoporosis
Time frame: up to 12 month
EuroQol-5D (EQ-5D): an instrument for measuring quality of life
EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: up to 12 month