Local and Systemic Changes in Osteonecrosis of the Jawbone

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05329558

Acronym

SULVO

Enrollment

100

Registered

2022-04-15

Start date

2018-03-01

Completion date

2026-12-01

Last updated

2024-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteonecrosis of the Jaw

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 18 years or older * with/without ART * with/without MRONJ

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Austria

Outcome results