A Study on the Prevention and Treatment of GIOP With Eldecalcitol (ELEGANT)

Chinese SLE Treatment And Research Group

Status and phase: Not yet enrolling; Phase 4

Conditions: Osteopenia; Osteoporosis; Rheumatoid Arthritis

Treatments: Drug: Alfacalcidol tablets; Drug: Calcium carbonate tablets; Drug: Eldecalcitol capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT06385093

EDR-IIS-003

Details and patient eligibility

About

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.

Full description

After having signed informed consent (Day 0), the patients will be screened for enrollment. About 314 eligible patients will be enrolled in this study. The background information of eligible patients including demographic characteristics, history of present illness, medical history, treatment history, etc., related questionnaire, baseline bone mineral density (BMD), X-ray examination result, High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) examination result, quantitative ultrasound (QUS) examination result and lab test result will be collected at Day 0. After enrollment, the following information will be collected at 6 months and/or 12 months: related questionnaire, BMD, X-ray examination result, HR-pQCT examination result, QUS examination result and lab test result, medication adherence and AE information.

Enrollment: 314 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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314 participants in 2 patient groups

Eldecalcitol

Experimental group

Description:

Participants receive oral eldecalcitol 0.75μg daily for 12 months

Treatment:

Drug: Eldecalcitol capsules

Alfacalcidol + calcium carbonate

Active Comparator group

Description:

Participants receive oral calcitriol 0.5μg daily and 1.5g calcium carbonate daily for 12 months

Treatment:

Drug: Alfacalcidol tablets

Drug: Calcium carbonate tablets