NCT05329558

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Mar 2018Dec 2026

Study Start

First participant enrolled

March 1, 2018

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

7.8 years

First QC Date

February 22, 2022

Last Update Submit

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
  • with/without ART
  • with/without MRONJ

You may not qualify if:

  • smoker (\>10 cigarettes/day)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

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

Primary Completion

January 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 5, 2024

Record last verified: 2024-04

Locations

AU(1)