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SULVO: Local and Systemic Changes in Osteonecrosis of the Jawbone

Sponsor
Medical University of Graz (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05329558
Collaborator
(none)
100
Enrollment
1
Location
69
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Pilot Study: Local and Systemic Changes in Osteonecrosis of the Jawbone
    Actual Study Start Date :
    Mar 1, 2018
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy Controls
    Patients with ART without MRONJ
    Patients with oral ART with MRONJ
    Patients with intravenous ART with MRONJ

    Outcome Measures

    Primary Outcome Measures

    1. target gene expression [through study completion, an average of 1 year]

      differences in gene expression recorded by qPCR will be assessed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 18 years or older

    • with/without ART

    • with/without MRONJ

    Exclusion Criteria:

    • smoker (>10 cigarettes/day)

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Graz Graz Austria 8036

    Sponsors and Collaborators

    • Medical University of Graz

    Investigators

    • Principal Investigator: Stephan Acham, Medical University of Graz

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Foessl, Ines, MSc, Investigator, Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT05329558
    Other Study ID Numbers:
    • 30-196 ex 17/18
    First Posted:
    Apr 15, 2022
    Last Update Posted:
    Apr 15, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteonecrosis

    Study Results

    No Results Posted as of Apr 15, 2022