Local and Systemic Changes in Osteonecrosis of the Jawbone

Osteonecrosis of the Jaw Clinical Trial

— SULVO  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05329558
• Other study ID #: 30-196 ex 17/18
• Status: Enrolling by invitation
• Start date: March 1, 2018
• Est. completion date: December 1, 2026

Study information

• Verified date: April 2024
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• with/without ART

• with/without MRONJ

Exclusion Criteria:

• smoker (>10 cigarettes/day)

• pregnancy

Related Conditions & MeSH terms

• Osteonecrosis
• Osteonecrosis of the Jaw

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target gene expression	differences in gene expression recorded by qPCR will be assessed	through study completion, an average of 1 year