Glucocorticoid-induced osteoporosis
Conditions
Interventions
Denosumab group (Denosmab 60mg/month and vitamin D)
Bisphosphonate group (bisphosphonate and vitamin D)
Sponsors
Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In adult (>= 20-year-old) patients with systemic rheumatic diseases, such as rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, Sjogren's syndrome, mixed connective tissue disease, systemic vasculitides, Behcet's disease, polymyalgia rheumatica, receiving systemic glucocorticoids at the averaged dose of 2.5 mg prednisolone equivalent daily or more and in whom treatment for glucocorticoid-induced osteoporosis was recommended according to the guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for Bone and Mineral Research, patients who developed new fragility fractures; or whose bone mineral density values in lumbar spine or femoral neck was below 80% of young adult mean (YAM) and had not increased by 2% over 12 months during treatment with an oral bisphosphonate and a vitamin D analogue for 12 months; or whose bone mineral density values in lumbar spine or femoral neck was below 70% of YAM or was equal to or below -2.5 by T-score were included in this study.
Exclusion criteria
Exclusion criteria: Persons who had allergy to ingredients of denosmab injection, hypocalcemia, plan for invasive dental therapy, such as dental extraction, previous or current use of denosmab or teriparatide, and renal dysfunction with estimated glomerular filtration rate below 30% were excluded. Pregnant and breastfeeding women, woman who have plan for pregnancy, and persons judged as ineligible for this study by attending physician were also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of bone mineral density of lumbar spine and femoral neck from baseline to 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of bone markers from baseline to 12 months. | — |
Countries
Japan
Contacts
Public ContactShin-ichiro Ohmura
Nagoya City University Hospital Division of Respiratory Medicine, Allergy and Rheumatology
Outcome results
None listed