osteoporosis, rheumatoid arthritis
Conditions
Interventions
monthly risedronate sodium 75mg for 6 months
monthly placebo for 6 months
Sponsors
Division of rheumatology, endcrinology and nephrology, Hokkaido University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Rheumatoid arthritis patients with osoteoporosis receiving corticosteroid for more than 3 months. In addition, patients who have more than 3 in the risk factor scores in Japanese guideline for the management and treatment in patients with corticosteroid induced osteoporosis.
Exclusion criteria
Exclusion criteria: Patients who received drugs for osteoporosis within 2 months at inclusion of the study except alphacalcidol and calcitriol Patients who had received bisphosphonates Patients who had undergone the operation of lumbar spine Patients who have a severe decayed tooth to be treated Patients who are considered to be contraindicated for bisphosphonates Patients who are thought to be inappropriate for this study by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in the bone mineral density of lumbar spine (L2-4) at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in the bone mineral density of femoral neck and total hip at 6 months Incidence of vertebral fractures at 6 months Change from baseline in bone metabolic markers such as TRACP-5b and BAP at 6 months Change from baseline in disease activity score 28 (DAS28) at 6 months | — |
Countries
Japan
Contacts
Public ContactNao Horie
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Outcome results
None listed