A Study on the Prevention and Treatment of GIOP With Eldecalcitol

Launched by CHINESE SLE TREATMENT AND RESEARCH GROUP · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Eldecalcitol to see if it can help prevent bone loss in patients with rheumatoid arthritis who are taking glucocorticoids (a type of steroid medication). The trial aims to include about 314 adult patients who have been living with rheumatoid arthritis and have been on a daily dose of glucocorticoids for at least three months. To be eligible, participants need to be at least 18 years old and able to walk independently. They will be randomly assigned to receive either Eldecalcitol or another medication called Alfacalcidol for one year, with follow-up visits at six and twelve months to monitor their progress.

It's important to note that some people may not be eligible for this trial if they have certain health conditions, such as severe bone disorders or a history of specific fractures. Participants will be fully informed about the study and must give their written consent to join. This trial is currently not recruiting participants, but it will provide valuable information about how effective and safe Eldecalcitol is for protecting bone health in people with rheumatoid arthritis who require glucocorticoids.

Gender

ALL

Eligibility criteria

• 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 entry; or received subcutaneous anti-RANKL antibody at any time prior to study entry
• • 6. Urolithiasis at screening or had a history of urolithiasis
• • 7. Hypercalcemia (serum calcium \>10.4 mg/dL), or hypercalciuria (fasting morning urine calcium/creatinine \>400 mg/gCr or 24h urine calcium \>300mg), or had serum creatinine levels above the reference range
• • 8. Severe liver disease such as cirrhosis or serious heart disease such as severe heart failure
• • 9. Active malignant tumors or a history of malignant tumors within 5 years before informed consent obtained
• • 10. History of allergy to vitamin D
• • 11. Pregnant women or female patients planning to become pregnant during the study
• • 12. Other inappropriate situations judged by investigators