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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

314

participants targeted

Target at P75+ for phase_4 rheumatoid-arthritis

Timeline

Completed

Started Jun 2024

Shorter than P25 for phase_4 rheumatoid-arthritis

Geographic Reach

1 country

7 active sites

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

April 9, 2024

Completed

16 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed

1 month until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed

Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

1.5 years

First QC Date

April 9, 2024

Last Update Submit

April 23, 2024

Conditions

Rheumatoid Arthritis Osteoporosis Osteopenia

Keywords

Rheumatoid ArthritisOsteoporosisRandomized Controlled TrialGlucocorticoidsEldecalcitol

Outcome Measures

Primary Outcomes (1)

Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD)
BMD will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by blinded independent central review.
Baseline and 12 months

Secondary Outcomes (14)

Percent change from baseline to month 6 in lumbar spine (L1-4) BMD
Baseline and 6 months
Percent change from baseline in total hip BMD
Baseline, 6 months and 12 months
Percent change from baseline in femoral neck BMD
Baseline, 6 months and 12 months
Percent change from baseline to month 12 in broadband ultrasound attenuation (BUA) and speed of sound (SOS) measured by quantitative ultrasound (QUS)
Baseline and 12 months
Percent change from baseline in Procollagen Type 1 N-telopeptide (P1NP)
Baseline, 6 months and 12 months
+9 more secondary outcomes

Study Arms (2)

Eldecalcitol

EXPERIMENTAL

Participants receive oral eldecalcitol 0.75μg daily for 12 months

Drug: Eldecalcitol capsules

Alfacalcidol + calcium carbonate

ACTIVE COMPARATOR

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

Drug: Alfacalcidol tabletsDrug: Calcium carbonate tablets

Interventions

Eldecalcitol capsulesDRUG

Oral eldecalcitol 0.75μg daily

Also known as: Edirol

Eldecalcitol

Alfacalcidol tabletsDRUG

Oral Alfacalcidol 0.5μg daily

Alfacalcidol + calcium carbonate

Calcium carbonate tabletsDRUG

1.5g Calcium carbonate daily

Alfacalcidol + calcium carbonate

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\. 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.
\. 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.
\. Ambulant outpatients
\. Written informed consent

You may not qualify if:

\. BMD T\<-3.0 measured by DXA at screening
\. Vertebral, hip, proximal humerus, pelvis, or distal forearm fragility fracture history
\. Any severe bone disorder or deformation at the lumbar spine that would affect DXA measurement
\. Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadal insufficiency, osteogenesis impotence, poorly controlled diabetes mellitus (HbA1c\>9%), or other diseases that can affect bone metabolism
\. 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
\. Urolithiasis at screening or had a history of urolithiasis
\. 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
\. Severe liver disease such as cirrhosis or serious heart disease such as severe heart failure
\. Active malignant tumors or a history of malignant tumors within 5 years before informed consent obtained
\. History of allergy to vitamin D
\. Pregnant women or female patients planning to become pregnant during the study
\. Other inappropriate situations judged by investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Chinese SLE Treatment And Research Grouplead
Beijing Life oasis public service centercollaborator

Study Sites (7)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Aerospace Central Hospital