Clinical trial NCT06385093: A Study on the Prevention and Treatment of GIOP With Eldecalcitol
Official title: Efficacy and Safety of Eldecalcitol in Preventing Glucocorticoid-induced Bone Loss in Rheumatoid Arthritis Patients (ELEGANT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Osteoporosis
Osteopenia
Keywords: Rheumatoid Arthritis
Osteoporosis
Randomized Controlled Trial
Glucocorticoids
Eldecalcitol
Lead sponsor: Chinese SLE Treatment And Research Group
Sponsor class: OTHER
Collaborators: name: Beijing Life oasis public service center
First posted: 2024-04-25
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD)
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Percent change from baseline to month 6 in lumbar spine (L1-4) BMD
timeFrame: Baseline and 6 months
measure: Percent change from baseline in total hip BMD
timeFrame: Baseline, 6 months and 12 months
measure: Percent change from baseline in femoral neck BMD
timeFrame: Baseline, 6 months and 12 months
measure: Percent change from baseline to month 12 in broadband ultrasound attenuation (BUA) and speed of sound (SOS) measured by quantitative ultrasound (QUS)
timeFrame: Baseline and 12 months
measure: Percent change from baseline in Procollagen Type 1 N-telopeptide (P1NP)
timeFrame: Baseline, 6 months and 12 months
measure: Percent change from baseline in Type 1 Collagen C-telopeptide (CTX)
timeFrame: Baseline, 6 months and 12 months
measure: Percentage of patients diagnosed with osteoporosis at month 12
timeFrame: Baseline and 12 months
measure: Incidence of new vertebral fracture
timeFrame: Baseline and 12 months
measure: Change from baseline in Quality of Life assessed using EQ-5D-5L
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score
timeFrame: Baseline, 6 months and 12 months
measure: Percent change from baseline to month 12 in volumetric bone mineral density (vBMD) measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)
timeFrame: Baseline and 12 months
measure: Percent change from baseline to month 12 in bone microarchitecture measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)
timeFrame: Baseline and 12 months
measure: Percent change from baseline to month 12 in bone geometry measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Aerospace Central Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Shijingshan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Shunyi hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Mengtao Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Weibo Xia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Ying Jiang, MD
role: STUDY_DIRECTOR
References: