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Efficacy on zoledronate therapy for DSO

Efficacy on zoledronate therapy for diffuse sclerosing osteomyelitis of the mandible - Efficacy on zoledronate therapy for diffuse sclerosing osteomyelitis of the mandible

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051180011
Enrollment
8
Registered
2018-12-04
Start date
2018-09-28
Completion date
Unknown
Last updated
2026-06-29

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 mandible

Interventions

Sponsors

Akashi Masaya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Pain score(visual analogue scale:VAS) of the mandible after one year from the administration of zoledronate.

Secondary

MeasureTime frame
The duration of pain control

Contacts

Public ContactMasaya Akashi

Kobe University Hospital

akashim@med.kobe-u.ac.jp+81-78-382-6213

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026