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Evaluation of Usefulness of BP for DSO

Evaluation of Usefulness of Bisphosphonate for diffuse sclerosing osteomyelitis of the jaw - Evaluation of Usefulness of Bisphosphonate for diffuse sclerosing osteomyelitis of the jaw

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs011180002
Enrollment
13
Registered
2018-11-16
Start date
2018-07-20
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Diffuse Sclerosing Osteomyelitis of the jaw DSO

Interventions

A 30-mg dose of pamidronate will be administrated intravenously for 4 hours under hospitalization. One treatment is a single dose

Sponsors

Kimura Taku
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Change of Visual Analogue Scale (VAS) of pain after administaration of bisphosphonate

Secondary

MeasureTime frame
1) Safety: general morbidities,side effects 2) SUVmax of the FDF-PET 3) correlation between Bone scintigraphy and pain area

Contacts

Public ContactTakuya Asaka

HokkaidoUniversityHospital

asakatakuya@den.hokudai.ac.jp+81-11-706-4280

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026