Efficacy on zoledronate therapy for DSO

JRCT ID: jRCTs051180011

Registered date:04/12/2018

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: diffuse sclerosing osteomyelitis of the mandible
• Date of first enrollment: 28/09/2018
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Single administration of zoledronate(4mg)

Outcome(s)

• Primary Outcome: Pain score(visual analogue scale:VAS) of the mandible after one year from the administration of zoledronate.
• Secondary Outcome: The duration of pain control

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

The patient meets all the following criteria to qualify.
(1) During informed consent in patients is over 18 years old.
(2) Patients with clinical symptoms, panoramic x-rays, mandible CT or MRI findings and blood examinations, was diagnosed with the DSO.
(3) Participation in this study, patients with written consent by the free will of the person in question.

Exclude criteria

As to exclude patients with any one of the following.
(1)Patients not diagnosed with the DSO, based on clinical symptoms, panoramic x-rays, mandible CT or MRI findings and blood tests showed.
(2) Before blood tests on patients under serum Ca 8.6 mg/dl.
(3) Patients with severe liver dysfunction (serum AST or ALT values> 70 IU / l or T-BIL> 2.0 mg / dl)
(4) Patients with severe renal dysfunction (eGFR <30 ml / min).
(5)Patients with drug hypersensitivity such as allergies.
(6)QT prolongation due to hypocalcemia, cramps, tetany, numbness, disorientation history of recognition, etc.
(7)Patients with complications of medication-related osteonecrosis of the jaw or history.
(8)Patients with a bisphosphonate dose history for DSO within 2 years.
(9)Patients during administration of a bisphosphonate or Denosumab or a dose history for diseases except DSO.
(10)Patients with risk factors for drug-related bone necrosis listed below
malignant tumors, angiogenesis inhibitors, corticosteroids treatment, radiation therapy
(11) Patients with otitis externa, ear discharge, the symptoms of ear pain, etc.
(12)Patients using calcitonin preparations, aminoglycoside antibiotics, cinacalcet.
(13) Pregnant women and patients who may be pregnant or breast-feeding patients.
(14)Patients who participated in other clinical trials within 4 months.
(15)In addition, patients judged inappropriate by the person in charge of this study.

Related Information

• Primary Sponsor: Akashi Masaya
• Secondary ID(s): UMIN 000031227