Steroid induced osteoporosis
Conditions
Interventions
the Alendronate IV infusion 4 weekly treatment group
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 the following criteria are targeted. 1) Guidelines for prevention and treatment of steroid osteoporosis Patients meeting the 2014 version (one of the following) 1.Patients with existing vulnerability fractures 2.Patients planning to administer 7.5 mg / day or more in terms of prednisolone 3.Patients over 65 years old 4.Patients with lumbar spine bone density (YAM) less than 70% 5.Patients who are 50 years of age or older, scheduled to be administered at a dose of 5 mg / day or more in terms of prednisolone, patients satisfying any two of YAM of 70 to less than 80% 2) Patients receiving steroid for the first time 3) Patients aged 18 years or older at the time of acquiring consent (regardless of gender) 4) After receiving sufficient explanation for the participation of this clinical study, patients who obtained document consent by the patient's free will with sufficient understanding
Exclusion criteria
Exclusion criteria: Patients who conflict with any of the following will not be included in this clinical study. 1) Patients with a history of hypersensitivity to bisphosphonates 2) Patients with hypocalcemia 3) Patients with disorders delaying esophageal stenosis or esophageal passage such as achalasia 4) Patients who are raising the upper body for more than 30 minutes or who can not stand 5) Patients with AST or ALT more than twice the institution standard value 6) Patients with serum creatinine> 2.0 mg / dL 7) Patients who received osteoporosis treatment drug within 6 months before treatment 8) Patients who participated in other clinical studies (including clinical trials) within 6 months 9) Patients who underwent oral steroid and steroid pulse therapy within 2 years 10) If you do not obtain consent from the substitute 11) Others who judged that the researcher is inappropriate as the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endopoint is the Lumbar spine (L1-L4) bone density change rate 52 weeks after administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints were the rate of change of bone metabolism markers (P1NP and TRACP-5b) during the observation period, morphological vertebral fractures and clinical fractures of the observation period, rate of change of the lumbar TBS after 52 weeks of administration, 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