Denosumab and Screw Fixation for Osteoporotic Compression Fracture

  • STATUS
    Recruiting
  • day left to enroll
    1
  • participants needed
    125
  • sponsor
    Shenzhen People's Hospital
Updated on 9 October 2021
Accepts healthy volunteers

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

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

Details
Condition Denosumab and Screw Internal Fixation of Osteoporotic Vertebral Compression Fracture
Treatment Denosumab
Clinical Study IdentifierNCT05065164
SponsorShenzhen People's Hospital
Last Modified on9 October 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
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
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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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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