NCT05329558

Enrolling By Invitation

Local and Systemic Changes in Osteonecrosis of the Jawbone

Medical University of Graz Source

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Other study identifiers

Sponsor study identifier

30-196 ex 17/18

Study Type

observational

Estimated enrollment

100

Locations

1 country

Sites

1

Timeline

Study Start

March 1, 2018

Actual (reported)

Primary Completion

January 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 1, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: enrolling by invitation
Estimated enrollment: 100 participants
Study completion date: December 1, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 1, 2018
Actual (reported)
First Submitted
February 22, 2022
Actual (reported)
First Posted
April 15, 2022
Actual (reported)
Primary Completion
January 1, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: April 5, 2024
Status Verified: April 2024
Last Update Submitted: April 4, 2024

Conditions

Osteonecrosis of the Jaw

Outcome Measures

Primary Outcomes (1)

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

Study Arms (4)

Healthy Controls

Patients with ART without MRONJ

Patients with oral ART with MRONJ

Patients with intravenous ART with MRONJ

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients at the Department of Oral Surgery and Radiology, University Clinic for Oral and Maxillofacial Medicine, Graz, Austria

You may qualify if:

years or older

Sponsors & Collaborators

Medical University of Graz
Otherlead

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Biospecimen

Retention: SAMPLES WITH DNA

blood, plasma, serum, saliva, tissue

Study Officials

Stephan Acham
Medical University of Graz
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Investigator

Study Record Dates

First Submitted

February 22, 2022

First Posted

April 15, 2022

Study Start

March 1, 2018

Actual (reported)

Primary Completion

January 1, 2026

Estimated (date passed)

NCT01967160

Osteonecrosis of the Jaw (ONJ) and Infection Among Nordic Cancer Patients Treated With XGEVA™ or Zoledronic Acid

Completed

NCT07588269

Bone Quality Evolution in Medication-Related Osteonecrosis of the Jaw Assessed by CBCT (B-ONJ EVOL)

Not Yet Recruiting

NCT06457776

Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs

Recruiting

NCT06622421

Piezoeletric Surgery vs Conventional Surgery for Treatment of MRONJ

Not ApplicableNot Yet Recruiting

with/without ART

with/without MRONJ

You may not qualify if:

smoker (\>10 cigarettes/day)
pregnancy

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 1, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

April 5, 2024

Record last verified: 2024-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05329558
Data provider: ClinicalTrials.gov
Source updated: 2024-04-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:31 UTC

Locations

AT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

Healthy Controls

Patients with ART without MRONJ

Patients with oral ART with MRONJ

Patients with intravenous ART with MRONJ

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations