Attending Physician of Shenzhen People's Hospital
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- age
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
zoledronic acid
intravenous zoledronic acid and placebo /6 months subcutaneously
Intervention: Zoledronic acid (Drug)
denosumab
Denosumab 60mg/6 months subcutaneously + placebo intravenous
Intervention: Denosumab (Drug)
Outcomes
Primary Outcomes
age
Time Frame: up to 12 months
participants age
sex
Time Frame: up to 12 months
participants sex
height
Time Frame: up to 12 months
participants height cm
BMI
Time Frame: up to 12 months
participants body mass index
serum osteocalcin
Time Frame: up to 12 months
osteocalcin in the N terminal molecular fragment
serum Procollagen type 1 n-terminal propeptide P1NP
Time Frame: up to 12 months
Procollagen type 1 n-terminal propeptide
serum C-terminal cross-linked type 1 collagen terminal peptide CTX
Time Frame: up to 12 months
C-terminal cross-linked type 1 collagen terminal peptide
Serum total calcium
Time Frame: up to 12 months
Serum total calcium level
lumber spine bone mineral density
Time Frame: up to 12 months
Dual energy X ray for lumber spine bone mineral density
hip bone mineral density
Time Frame: up to 12 months
DEXA for hip bone mineral density
MRI for lumber
Time Frame: up to 12 months
Bone marrow edema and adjacent intervertebral disc were detected by MRI
pain visual analogue scores (VAS)
Time Frame: 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 Outcomes
- The Roland-Morris Disability Questionnaire(up to 12 month)
- QUALEFFO-31(up to 12 month)
- EuroQol-5D (EQ-5D)(up to 12 month)