Bone mineral density and function at 1 year after screw fixation with denosumab vs zoledronic acid for osteoporotic vertebral compression fractures: 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 of osteoporotic vertebral compression fracture (OVCF) were compared 1 year after screw internal fixation with denosumab vs zoledronic acid in Shenzhen People's Hospital from September, 2021 to November, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
122
Denosumab 60mg/6 months subcutaneously + placebo iv
Iv zoledronic acid and placebo /6 months subcutaneously
ShenzhenPH
Shenzhen, Guangdong, China
RECRUITINGage
participants age
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
BMI
participants body mass index
Time frame: up to 12 months
serum osteocalcin
osteocalcin in the N terminal molecular fragment
Time frame: up to 12 months
serum Procollagen type 1 n-terminal propeptide P1NP
Procollagen type 1 n-terminal propeptide
Time frame: up to 12 months
serum 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
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
DEXA for hip bone mineral density
Time frame: up to 12 months
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MRI for 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. There is a wide variability of terms used to describe each category and the rating may be divided into four (0 -3) or six (0 -5) categories. Patients score their pain intensity from absent (0) to severe (3) or from none (0) to very severe (5)
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. The questionnaire assesses quality of life in the aspect of pain, physical function, social function, general health, and mental health
Time frame: up to 12 month
EuroQol-5D (EQ-5D)
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