Desomumab vs Zoledronic Acid and Osteoporotic Compression Fracture

  • STATUS
    Recruiting
  • days left to enroll
    60
  • participants needed
    122
  • sponsor
    Shenzhen People's Hospital
Updated on 11 November 2021
Accepts healthy volunteers

Summary

Bone mineral density and function at 1 year after screw fixation with desomumab vs zoldronic acid for osteoporotic vertebral compression fractures: a parallel double-blind randomized controlled clinical trial

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 desomumab 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.

Details
Condition Denosumab vs Zoledronate
Treatment Zoledronic Acid, Denosumab
Clinical Study IdentifierNCT05106517
SponsorShenzhen People's Hospital
Last Modified on11 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must be age between 40 and 90 years old
X-ray diagnosis of 1-2 vertebral compression fractures
DEXA test BMD T value was 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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