Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture
- Conditions
- Denosumab vs Zoledronate
- Interventions
- Registration Number
- NCT05106517
- Lead Sponsor
- Shenzhen People's Hospital
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 122
- Must be age between 40 and 90 years old
- X-ray diagnosis of 1-2 vertebral compression fractures
- Dual eneragy X ray test for bone mineral density T value less than -1
- fracture history lasted within 6 weeks
- Must be MRI showed bone marrow edema of injured segment
- Must be lower back pain, local spines tenderness
- Must be able to have no posterior vertebral wall fracture
- Must be able to have no patients with 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 calcium level ≤2.13 mmol/L
- 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 surgery
- Must be able to have no other established contraindications for elective surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description zoledronic acid Zoledronic acid intravenous zoledronic acid and placebo /6 months subcutaneously denosumab Denosumab Denosumab 60mg/6 months subcutaneously + placebo intravenous
- Primary Outcome Measures
Name Time Method age up to 12 months participants age
sex up to 12 months participants sex
height up to 12 months participants height cm
BMI up to 12 months participants body mass index
serum osteocalcin up to 12 months osteocalcin in the N terminal molecular fragment
serum Procollagen type 1 n-terminal propeptide P1NP up to 12 months Procollagen type 1 n-terminal propeptide
serum C-terminal cross-linked type 1 collagen terminal peptide CTX up to 12 months C-terminal cross-linked type 1 collagen terminal peptide
Serum total calcium up to 12 months Serum total calcium level
lumber spine bone mineral density up to 12 months Dual energy X ray for lumber spine bone mineral density
hip bone mineral density up to 12 months DEXA for hip bone mineral density
MRI for lumber up to 12 months Bone marrow edema and adjacent intervertebral disc were detected by MRI
pain visual analogue scores (VAS) up to 12 months 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)
- Secondary Outcome Measures
Name Time Method The Roland-Morris Disability Questionnaire up to 12 month 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.
QUALEFFO-31 up to 12 month 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
EuroQol-5D (EQ-5D) up to 12 month 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.
Trial Locations
- Locations (1)
ShenzhenPH
🇨🇳Shenzhen, Guangdong, China