Clinical trial NCT05106517: Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture
Official title: Attending Physician of Shenzhen People's Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Denosumab vs Zoledronate
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 122
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: age
timeFrame: up to 12 months
measure: sex
timeFrame: up to 12 months
measure: height
timeFrame: up to 12 months
measure: BMI
timeFrame: up to 12 months
measure: serum osteocalcin
timeFrame: up to 12 months
measure: serum Procollagen type 1 n-terminal propeptide P1NP
timeFrame: up to 12 months
measure: serum C-terminal cross-linked type 1 collagen terminal peptide CTX
timeFrame: up to 12 months
measure: Serum total calcium
timeFrame: up to 12 months
measure: lumber spine bone mineral density
timeFrame: up to 12 months
measure: hip bone mineral density
timeFrame: up to 12 months
measure: MRI for lumber
timeFrame: up to 12 months
measure: pain visual analogue scores (VAS)
timeFrame: up to 12 months
Secondary outcomes:
measure: The Roland-Morris Disability Questionnaire
timeFrame: up to 12 month
measure: QUALEFFO-31
timeFrame: up to 12 month
measure: EuroQol-5D (EQ-5D)
timeFrame: up to 12 month
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: ShenzhenPH
state: Guangdong
Study officials:
References: