Evaluation of Usefulness of BP for DSO

Phase 2

Recruiting

• Conditions: Diffuse Sclerosing Osteomyelitis of the jaw; DSO

• Registration Number: JPRN-jRCTs011180002
• Lead Sponsor: Kitagawa Yoshimasa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Patients suspected diffuse sclerosing osteomyelitis of jaw clinically in Hokkaido university hospital. The final diagnosis of DSO is determined as follows in the conference by oral surgery specialist.
1Recurrent pain and swelling of the mandible, with no sign of infection with microorganisms.
2CT images of DSO patients showed an intermingled sclerotic and lytic pattern in the cortex and medulla.
3Antimicrobial treatment has not proved to be effective.
4No history of irradiation to the maxillofacial area and received long-term bisphosphonate therapy.

Inclusion Criteria
1over 15 years old
2written informed consent
3Performance Status 0 or 1

Exclusion Criteria

1)Patients diagnosed Anti-resorptive agents-related ONJ
2)Patients who received other bisphosphonate.
3)Children of 15 years or under.
4)pregnancy, nursing woman or possibly pregnant woman.
5)Patients with severe renal disorders(BUN:=<1.5 upper limit of normal,Cr:=<1.5 upper limit of normal)
6)patients who are contraindications for Voltaren
7)patient that physician determined inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of Visual Analogue Scale (VAS) of pain after administaration of bisphosphonate

Secondary Outcome Measures

Name	Time	Method
1) Safety: general morbidities,side effects <br>2) SUVmax of the FDF-PET <br>3) correlation between Bone scintigraphy and pain area