Clinical trial NCT05065164: Denosumab and Screw Fixation for Osteoporotic Compression Fracture
Official title: Attending Doctor of Shenzhen People's Hospital
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Denosumab Allergy
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 0
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: 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

Eligibility criteria: Inclusion Criteria:• 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

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 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

Primary outcomes:
measure: age
timeFrame: up to 12 months
measure: sex
timeFrame: up to 12 months
measure: height
timeFrame: up to 12 months
measure: weight
timeFrame: up to 12 months
measure: BMI
timeFrame: up to 12 months
measure: osteocalcin
timeFrame: up to 12 months
measure: Procollagen type 1 n-terminal propeptide P1NP
timeFrame: up to 12 months
measure: 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: parathyroid hormone
timeFrame: up to 12 months
measure: albumin
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 of 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): an instrument for measuring quality of life
timeFrame: up to 12 month
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: ShenzhenPH
state: Guangdong
Study officials:
affiliation: Shenzhen People's Hospital
name: Hongyu Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: