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Enrolling by invitation NCT05329558

Local and Systemic Changes in Osteonecrosis of the Jawbone

Observational Osteonecrosis of the Jaw

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Osteonecrosis of the Jaw. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Pilot Study: Local and Systemic Changes in Osteonecrosis of the Jawbone

Overview

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.

Primary outcome measures

  • target gene expression [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • smoker (>10 cigarettes/day)
  • pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Austria · 1 center
  • Medical University of Graz — Graz

Identifiers

NCT: NCT05329558 · 30-196 ex 17/18

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗