Study to the effect of teriparatide formulation Forteo versus Teribon on bisphosphonate-related osteonecrosis of the jaw in osteoporosis patients.
- Conditions
- bisphosphonate-related osteonecrosis of the jaw
- Registration Number
- JPRN-UMIN000009132
- Lead Sponsor
- Faculty of Medicine, Kagawa University
- Brief Summary
TPTD treatment with MRONJ led to partial remission or complete remission in 5 daily-group patients and 3 weekly-group patients. The MRONJ stage was significantly improved from baseline to 6 months of treatment in the entire series of 12 patients (p = 0.008); the weekly group did not show significant improvement, but the daily group did (p = 0.01).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 13
Not provided
1) Hypercalcemic disorders 2)Potential risk of osteocarcoma (1)Patients with Paget's disease of bone (2)Unexplained elevations of alkaline phosphatase. (3)Young adult patients with open epiphyses. (4)Patients with prior external beam or implant radiation involving the skeleton. 3)Patients with bone metastases, history of skeletal malignancies. 4)Metabolic bone diseases other than osteoporosis. 5)Pregnancy or women with suspected pregnancy. 6)Patients with hypersensitivity to teriparatide or to any of its excipients. 7)Serious cardiac disease, serious hepatic disorder , renal disease. 8)Use of active vitamin D3 or Digoxin. 9)The patients who could not be provided with informed consent. 10)Unsuitability for the trial based on clinical judgement.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pain bone formation
- Secondary Outcome Measures
Name Time Method