Steroid induced osteoporosis
Conditions
Interventions
the denosumab subcutaneous injection 6 months once treatment group
the the Alendronate oral weekly treatment group
Sponsors
The First Department of Internal Medicine University of Occupational and Environmental Health, Japan, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who satisfy all of the following criteria are included in this study. 1)Patients over 18 years old, male and female unquestioned 2)Guidelines for management and treatment of steroid osteoporosis: Patients with a score of 3 or more with the 2014 algorithm
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endopoint is the bone density change after 6 months and 1 year at administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKeiichi Torimoto
University of Occupational and Environmental Health, Japan, School of Medicine The First Department of Internal Medicine
Outcome results
None listed