Denosumab and Screw Fixation for Osteoporotic Compression Fracture
- Registration Number
- NCT05065164
- Lead Sponsor
- Shenzhen People's Hospital
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
• Must be age between 40 and 90 years old
- X-ray diagnosis of 1-2 vertebral compression fractures
- Dual energy X ray test bone mineral density T value less than -1
- fracture history lasted within 6 weeks
- MRI showed bone marrow edema of injured segment
- 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 previous use of anti-osteoporosis drugs within 6 weeks
- 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 placebo control Denosumab Only Product Placebo subcutaneous injection /6 months, twice a year dnosumab Denosumab Only Product Desuzumab 60 mg subcutaneously /6 months, twice a year
- Primary Outcome Measures
Name Time Method albumin up to 12 months serum albumin level
height up to 12 months participants height cm
weight up to 12 months participants weight kg
BMI up to 12 months participants body mass index
osteocalcin up to 12 months osteocalcin in the N terminal molecular fragment
Procollagen type 1 n-terminal propeptide P1NP up to 12 months Procollagen type 1 n-terminal propeptide
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
parathyroid hormone up to 12 months serum parathyroid hormone level
sex up to 12 months participants sex
age up to 12 months participants age (year)
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 Dual energy X-ray for hip bone mineral density
MRI of 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, with 0 being "painless" and 100 being "the worst pain imaginable".
- 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
EuroQol-5D (EQ-5D): an instrument for measuring quality of life 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