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Search / Trial NCT03330340

Percutaneous Vertebroplasty Versus Conservative Treatment in GIOPVCF

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Nov 1, 2017

Trial Information

Current as of May 12, 2025

Unknown status

Keywords

Vertebral Compression Fracture Osteoporosis Glucocorticoids Vertebroplasty

ClinConnect Summary

Patient recruitment and informed consent The study will recruit patients with GIOPVCF after consultation with inpatients and outpatients. The principal investigator of the study will screen the clinical information and inform the patients whether they are eligible for the study. After explaining the two therapeutic strategies (conservative treatment and PVP) and signing the informed consent, the patients will be divided into conservative treatment or PVP group based on their own decision.

The general information and medicine history of the participants are collected: age, gender, original ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients have fresh vertebral compression fractures regarding spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone edema on MRI, focal tenderness on VCF level).
  • 2. Patients have back pain for 6 weeks or less, with a visual analogue scale (VAS) score equal or less than 5.
  • 3. GCs consumption for more than 3 months (prednisone equivalent or more than 5 mg daily).
  • 4. Reduced bone density with T-scores equal or less than -1.
  • 5. Age at 55 or higher.
  • -
  • Exclusion Criteria:
  • 1. Concurrent other secondary osteoporosis.
  • 2. Previous PVP procedure or other spinal surgery on thoracic or lumbar segments.
  • 3. Systemic or local infection in spine (osteomyelitis, spondylodiscitis)
  • 4. Unable to comply with study due to severe psychosis.
  • -

About Peking University First Hospital

Peking University First Hospital is a leading medical institution in China, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital leverages its extensive expertise in various medical fields to conduct rigorous studies aimed at improving patient outcomes and contributing to global medical knowledge. With a multidisciplinary team of skilled researchers and clinicians, Peking University First Hospital is dedicated to the ethical conduct of clinical research, ensuring the highest standards of safety and efficacy in its trials. The institution plays a vital role in translating scientific discoveries into effective treatments, thereby enhancing the quality of care for patients both locally and worldwide.

Locations

Patients applied

0 patients applied

Trial Officials

Chunde Li, Doctor

Study Director

Peking University First Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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