Local and Systemic Changes in Osteonecrosis of the Jawbone

• Conditions: Osteonecrosis of the Jaw

• Registration Number: NCT05329558
• Lead Sponsor: Medical University of Graz

Brief Summary

Osteonecrosis of the Jawbone (ONJ) is a serious complication of antiresorptive therapies (ARTs), for example with bisphosphonates or Denosumab. Especially long term treatment with intravenous antiresorptive agents causing lesions and, less frequent, also oral administration. This study aims at elucidating local and systemic changes in patients with ONJ.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2022-02-22
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2026-01-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 18 years or older
• with/without ART
• with/without MRONJ

Exclusion Criteria

• smoker (>10 cigarettes/day)
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
target gene expression	through study completion, an average of 1 year	differences in gene expression recorded by qPCR will be assessed

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria