Connective tissue diseases
Conditions
Interventions
Glucocorticoid + alfacalcidol 1 (0.5) microgram/day
Glucocorticoid + alendronate 35 mg/week
Glucocorticoid + alfacalcidol 1 (0.5) microgram/day + alendronate 35 mg/week
Sponsors
University of Occupational and Environmental Health, Japan
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients who are diagnosed as connective tissue diseases and are initially treated with more than 20 mg/day glucocorticoid (prednisolone)
Exclusion criteria
Exclusion criteria: 1) female who are pregnant 2) male 3) patients who are already diagnosed as osteoporosis 4) patients who are already treated with glucocorticoid 5) patients who are already treated with bisphosphonate 6) patients diagnosed as esophageal narrowing or esophageal achalasia 7) patients who cannot stand or sit for more than 30 minutes 8) patients sensitive to bisphosphonates 9) patients with hypocalcemia 10) patients who are not appropriate to the study by a doctor's judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Changes of bone metabolism markers at one week after the initiation of glucocorticoid therapy 2) Changes of bone metabolism at six months after the early intervention by alendronate in patients initially treated with glucocorticoid | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change of bone metabolism markers at 6 months after the initiation of glucocorticoid therapy 2) Correlation of the changes of bone markers at one week after the treatment with the changes of bone metabolism at six months after the treatement | — |
Countries
Japan
Contacts
Public ContactYosuke Okada
School of Medicine, University of Occupational and Environmental Health, Japan First Department of Internal Medicine
Outcome results
None listed