Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol (NCT01974167) | Clinical Trial Compass
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Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol
Japan400 participantsStarted 2013-12
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of eldecalcitol monotherapy compared with alfacalcidol monotherapy in patients with glucocorticoid-induced osteoporosis, using a randomized, open-label, parallel-group, comparative design.
Who can participate
Age range
20 Years – 85 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) Patients who are currently taking or plan to take oral glucocorticoid medication for 3 months or longer and thus require treatment as per the 'Guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for Bone and mineral Research (2004),' and who meet at least one of the conditions below. No restriction is imposed on the underlying disease treated with the oral glucocorticoid medication.
(i) Have any existing insufficiency fracture (ii) %YAM \<80 (iii) Oral glucocorticoid daily dose \>= 5 mg prednisolone equivalent
* (2) Aged between 20 and 85 years (both inclusive) at consent
* (3) Patients who are able to walk without assistance
* (4) Provided consent to participate in the study
Exclusion Criteria:
* (1) BMD (L1-4 or T-Hip) T score \< -3.5
* (2) Have 3 or more vertebral fractures between L1 and L4.
* (3) Have 1 or more SQ grade 3 vertebral fractures, or 3 or more SQ grade 2 vertebral fractures.
* (4) Have received a bisphosphonate preparation for 2 weeks or longer within 6 months before the start of study treatment.
* (5) Have received a bisphosphonate preparation for 2 years or longer within 3 years before the start of study treatment.
* (6) Have received a parathyroid hormone preparation before the start of study treatment.
* (7) Have received one or more doses of an anti-RANKL (receptor activator of nuclear factor-kappa B ligand) antibody.
* (8) Have received one or more doses of an anti-scl…
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
1
Percent change in lumbar spine (L1-4) bone mineral density
Timeframe: 12 months after the start of study drug administration