CompletedPhase 4

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

South Korea167 participantsStarted 2010-04

Plain-language summary

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

Who can participate

Age range

18 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Rheumatoid arthritis fulfilling the 1987 ACR criteria * Women equal and above 18 years, less than 75 years old * L1-4 T score less than -1.0 and equal or above -3.0 SD measured by DXA (Dual Energy X-ray Absorptiometry) * Patient must have taken prednisolone 5mg or its equivalent for more than 3 consecutive months within 1 year * Patient who would be taking glucocorticoids for more than 3 months after enrollment Exclusion Criteria: * Patient with vertebral fractures or nonvertebral fractures associated with osteoporosis * Patient diagnosed with malignancy within 5 years * Patient with endocrine dysfunction * RA functional class 4 * Patient who took bisphosphonates within 6 months * Patient on medication affecting bone mineral metabolism

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in L1-4 bone mineral density compared with baseline

Timeframe: 48 weeks

Trial details

NCT IDNCT01287533

SponsorYeong-Wook Song

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04

View on ClinicalTrials.gov More Rheumatoid Arthritis trials