Local & Systemic Changes in Osteonecrosis of the Jawbone

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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.

See also
Status	Clinical Trial	Phase
Completed	`NCT01666106` - Osteonecrosis of the Jaw (ONJ) Case Registry
Completed	`NCT01130389` - CONDOR Study of Osteonecrosis of the Jaws (TMJ)	N/A
Completed	`NCT01201330` - DPBRN Retrospective Cohort Study of Osteonecrosis of the Jaw	N/A
Completed	`NCT01967160` - Osteonecrosis of the Jaw (ONJ) and Infection Among Nordic Cancer Patients Treated With XGEVA™ or Zoledronic Acid

NCT number	NCT05329558
Study type	Observational
Source	Medical University of Graz
Contact
Status	Enrolling by invitation
Phase
Start date	March 1, 2018
Completion date	December 1, 2026

Local and Systemic Changes in Osteonecrosis of the Jawbone — SULVO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms