Trials Sponsors Conditions Drugs Pricing

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

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

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.

Sponsors & Collaborators

Beijing Life oasis public service center
Type not reportedcollaborator
Chinese SLE Treatment And Research Group
Otherlead

Study Sites (7)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Ying Jiang, MDCONTACT+86-13391701765 jiangying@pumch.cn

Aerospace Central Hospital

Beijing, Beijing Municipality, China

Jian LiuCONTACT

Beijing Luhe hospital, Capital Medical University

Beijing, Beijing Municipality, China

Baoyu ZhangCONTACT

Beijing Shijingshan Hospital

Beijing, Beijing Municipality, China

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoporosisBone Diseases, Metabolic

Interventions

eldecalcitolalfacalcidolCalcium Carbonate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

Mengtao Li, MD
Peking Union Medical College Hospital
PRINCIPAL INVESTIGATOR
Weibo Xia, MD
Peking Union Medical College Hospital
PRINCIPAL INVESTIGATOR
Ying Jiang, MD
Peking Union Medical College Hospital
STUDY DIRECTOR

Central Study Contacts

Mengtao Li, MD

CONTACT

+86-10-69158793 mengtao.li@cstar.org.cn

Ying Jiang, MD

CONTACT

+86-13391701765

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor and Director, Rheumatology and Immunology Department

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 25, 2024

Study Start

June 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 2025

A Study on the Prevention and Treatment of GIOP With Eldecalcitol

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Study Arms (2)

Eldecalcitol

Alfacalcidol + calcium carbonate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Study Arms (2)

Eldecalcitol

Alfacalcidol + calcium carbonate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations