NCT01287533

Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids

Efficacy of Monthly Ibandronate in Women With Rheumatoid Arthritis and Reduced Bone Mineral Density Receiving Long-term Glucocorticoids

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Yeong-Wook Song · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was to investigate the efficacy of oral monthly ibandronate in the management of glucocorticoid induced osteoporosis in women with rheumatoid arthritis.

Detailed description

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.

Conditions

• Rheumatoid Arthritis
• Osteoporosis
• Osteopenia

Interventions

Type	Name	Description
DRUG	Ibandronate	monthly dosage of ibandronate 150mg
DRUG	Placebo	monthly dosage of placebo

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2011-02-01
• Last updated: 2014-11-19

Locations

1 site across 1 country: South Korea