A Phase 4 interventional study of Ibandronate and Placebo in Rheumatoid Arthritis, Osteoporosis and Osteopenia, sponsored by Yeong-Wook Song. Completed at 1 site in South Korea. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-11-19.
Sponsored by Yeong-Wook Song · Phase 4, Interventional, and Prevention
This study was to investigate the efficacy of oral monthly ibandronate in the management of glucocorticoid induced osteoporosis in women with rheumatoid arthritis.
Glucocorticoid therapy is associated with a number of significant side effects, of which bone loss resulting in glucocorticoid-induced osteoporosis and an increase in fracture risk is the most serious. However studies show that many patients treated with glucocorticoids do not receive treatment to prevent bone loss. There exist 5 large randomized controlled clinical trials providing evidence that the bisphosphonates etidronate, alendronate, and risedronate are effective in both the prevention and the treatment of glucocorticoid-induced osteoporosis. Significant increases in BMD with bisphosphonate treatment, most consistently observed in lumbar spine, were seen in patients with many different glucocorticoid-treated disorders; most often RA and polymyalgia rheumatica, and occurred generally irrespective of patient age, sex and menopausal status in women. In addition, statically significant reductions in the absolute risk and relative risk of incident radiographic vertebral fractures were demonstrated after 1 year of treatment with risedronate. A similar significant reduction in the risk of incident radiographic vertebral fractures was seen in alendronate treated patients who completed 2 years of a study of alendronate in the prevention and treatment of glucocorticoid-induced osteoporosis. There exists a data about Ibandronate which reported that intermittent intravenous ibandronate reduced vertebral fracture risk in corticosteroid-induced osteoporosis. However, there is no report about oral monthly ibandronate. Current oral bisphosphonates, which are given either daily or weekly, are associated with stringent, inconvenient dosing schedules. Less frequent dosing may provide great acceptability. The objective of this study was to investigate the efficacy of oral monthly ibandronate in women receiving long-term glucocorticoids.
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 167 is above the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →This is the only study on the registry with Yeong-Wook Song as lead sponsor.
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Exclusion Criteria:
Ibandronate 150mg PO once every 4 weeks
Drug: Ibandronate
Placebo PO once every 4 weeks
Drug: Placebo
monthly dosage of ibandronate 150mg
monthly dosage of placebo
Changes in L1-4 bone mineral density compared with baseline
Time frame: 48 weeks
Changes in femur bone mineral density compared with baseline
Time frame: 48 weeks
Changes in L1-4 and femur bone mineral density compared with baseline
Time frame: 24 weeks
Changes in C-telopeptide compared with baseline
Time frame: 24 and 48 weeks
Cumulative incidence of vertebral fracture
Time frame: 48 weeks
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ibandronic Acid