Denosumab and Alendronate, Examination of the effective of Glucocorticoid-induced Osteoporosis
Not Applicable
Recruiting
- Conditions
- Steroid induced osteoporosis
- Registration Number
- JPRN-UMIN000033122
- Lead Sponsor
- The First Department of Internal Medicine University of Occupational and Environmental Health, Japan, School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
Patients falling under any of the following are excluded from this research. 1)Patients who may be pregnant or pregnant, patients who desire pregnancy 2)Patients already taking steroids 3)Patients receiving donosumab or bisphosphonate 4)Patient with a disorder delaying esophageal passage such as esophageal stenosis or achalasia (esophageal relaxation disorder) 5)Patients who are raising their upper body for more than 30 minutes or who can not stand 6)Patients with a history of hypersensitivity to denosumab and alendronate or other bisphosphonates. 7)Patients with hypocalcemia 8)Patients judged inappropriate as subjects by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endopoint is the bone density change after 6 months and 1 year at administration.
- Secondary Outcome Measures
Name Time Method Secondary endpoints are the change of bone metabolism markers during the observation period, morphological vertebral fractures and clinical fractures of the observation period, change of the lumbar TBS and adverse events.