Evaluation of Usefulness of BP for DSO

JRCT ID: jRCTs011180002

Registered date:16/11/2018

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diffuse Sclerosing Osteomyelitis of the jaw
• Date of first enrollment: 20/07/2018
• Target sample size: 13
• Study type: Interventional
• Intervention(s): A 30-mg dose of pamidronate will be administrated intravenously for 4 hours under hospitalization. One treatment is a single dose

Outcome(s)

• Primary Outcome: Change of Visual Analogue Scale (VAS) of pain after administaration of bisphosphonate

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Asaka Takuya