Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT06385093
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06385093
Study Brief:
Protocol Section:
NCT06385093