UnknownPhase 4

A Study on the Prevention and Treatment of GIOP With Eldecalcitol

China314 participantsStarted 2024-06

Plain-language summary

The study will be a multi-center, randomized, open label, parallel trial conducted in rheumatoid arthritis patients treated with glucocorticoids. After signing the informed consent, all patients will be screened as per the inclusion and exclusion criteria. Estimated 314 eligible patients will be enrolled. The enrolled patients will be randomly assigned to either Eldecalcitol group or Alfacalcidol group in a 1:1 ratio and followed up for 12 months. On-site follow up visits will be conducted at Month 6 and 12 after enrollment. The study is designed to evaluate the efficacy and safety of Eldecalcitol in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients.

Who can participate

Age range

18 Years

Sex

ALL

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: * 1\. Adult rheumatoid arthritis patients(≥18 years) who fulfilled the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism (EULAR) criteria. * 2\. Had been taking 5-10 mg oral prednisolone (or equivalent) daily glucocorticoids for longer than 3 months at screening and were expected to receive glucocorticoids for at least another 12 months. * 3\. Ambulant outpatients * 4\. Written informed consent Exclusion Criteria: * 1\. BMD T\<-3.0 measured by DXA at screening * 2\. Vertebral, hip, proximal humerus, pelvis, or distal forearm fragility fracture history * 3\. Any severe bone disorder or deformation at the lumbar spine that would affect DXA measurement * 4\. Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadal insufficiency, osteogenesis impotence, poorly controlled diabetes mellitus (HbA1c\>9%), or other diseases that can affect bone metabolism * 5\. Had injected bisphosphonate once or more within 3 years before entering the study; or had received oral bisphosphonate for 6 months or more in the 3 years prior to study entry; or had received parathyroid hormone once or more in the 3 years before entering the study; or received 2 weeks or more of calcitonin or vitamin K or selective estrogen receptor modulator or hormone replacement therapy or traditional Chinese medicine for osteoporosis within 2 months prior to study entry; or received active vitamin D within 2 weeks prior to study …

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

Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD)

Timeframe: Baseline and 12 months

Trial details

NCT IDNCT06385093

SponsorChinese SLE Treatment And Research Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Mengtao Li, MD

+86-10-69158793 mengtao.li@cstar.org.cn

View on ClinicalTrials.gov More Rheumatoid Arthritis trials