Local and Systemic Changes in Osteonecrosis of the Jawbone

NCT ID: NCT05329558

Last Updated: 2024-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2026-12-01

Brief Summary

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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

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Conditions

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Osteonecrosis of the Jaw

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Controls

No interventions assigned to this group

Patients with ART without MRONJ

No interventions assigned to this group

Patients with oral ART with MRONJ

No interventions assigned to this group

Patients with intravenous ART with MRONJ

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* smoker (\>10 cigarettes/day)
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Foessl, Ines, MSc

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephan Acham

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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30-196 ex 17/18

Identifier Type: -

Identifier Source: org_study_id

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