glucocorticoid-induced osteoporosis
Conditions
Interventions
The alendronate 35mg is administered before the glucocorticoid is administered to all cases. Afterwards, 5mg/day or 35mg/week of alendronate is additionally administered to the glucocorticoid administ
Sponsors
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The dosage of theglucocorticoid by prednisolone (PSL) conversion 20mg/day or more is a patient to whom administering for three months or more is scheduled. Or, the patient increased from a past amount of the glucocorticoid use to administering for three months or more by 20mg/day or more. Patient who received agreement of this research participation from person in question.
Exclusion criteria
Exclusion criteria: 1)Woman who hopes for pregnancy 2)Patient who has serious hepatopathy, renal damage, and cardiac disease 3)Patient who has received administering medicine that influences bone metabolism Medicine made of patient protein assimilation steroid(Winstrol, Primobolan, and Miotoron, etc.), Calcitonin(Elcitonin, Calcitriol, and Salmotonin, etc.), Ipriflavone(osten), vitamin K2(Glakey), androgenic hormone (TESTINON etc.), and female hormone (PREMARIN etc.), Raloxifene(Evista). However, after taking the medicine is stopped for eight weeks, it is possible to register. Patient who has received administering bisphosphonate. However, after taking the bisphosphonate is stopped for six months, it is possible to register. 4)Patient who judged it is improper to participation of physician in charge in clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The serum levels of BAP, OC, TRAP-5b and urinary levels of NTx are measured on days 0, 7 and at 1, 3, 6, 12 months after glucocorticoid treatment. Bone mineral density values are measured at the lumbar spine on day 0 and at 1, 3, 6, 12 months after glucocorticoid therapy. In all subjects, conventional thoracic and spinal radiographs in lateral and antero-posterior projections are obtained on day 0 and at 1 year after glucocorticoid therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The serum levels of total cholesterol, HDL cholesterol, triglycerides, glucose, insulin are measured on days 0, 7 and at 1, 3, 6, 12 months after glucocorticoid treatment. | — |
Countries
Japan
Outcome results
None listed