Attending Doctor of Shenzhen People's Hospital
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- albumin
Study Overview
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
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 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
Arms & Interventions
dnosumab
Desuzumab 60 mg subcutaneously /6 months, twice a year
Intervention: Denosumab Only Product (Drug)
placebo control
Placebo subcutaneous injection /6 months, twice a year
Intervention: Denosumab Only Product (Drug)
Outcomes
Primary Outcomes
albumin
Time Frame: up to 12 months
serum albumin level
sex
Time Frame: up to 12 months
participants sex
height
Time Frame: up to 12 months
participants height cm
weight
Time Frame: up to 12 months
participants weight kg
BMI
Time Frame: up to 12 months
participants body mass index
osteocalcin
Time Frame: up to 12 months
osteocalcin in the N terminal molecular fragment
Procollagen type 1 n-terminal propeptide P1NP
Time Frame: up to 12 months
Procollagen type 1 n-terminal propeptide
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
parathyroid hormone
Time Frame: up to 12 months
serum parathyroid hormone level
age
Time Frame: up to 12 months
participants age (year)
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
Dual energy X-ray for hip bone mineral density
MRI of 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, with 0 being "painless" and 100 being "the worst pain imaginable".
Secondary Outcomes
- The Roland-Morris Disability Questionnaire(up to 12 month)
- QUALEFFO 31(up to 12 month)
- EuroQol-5D (EQ-5D): an instrument for measuring quality of life(up to 12 month)