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

April 23, 2024 updated by: Mengtao Li, Chinese SLE Treatment And Research Group

Efficacy and Safety of Eldecalcitol in Preventing Glucocorticoid-induced Bone Loss in Rheumatoid Arthritis Patients (ELEGANT)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
314

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing, China
        • Beijing Shijitan Hospital
        • Contact:
          • Yuhua Wang
      • Beijing, Beijing, China
        • Xuanwu Hospital, Capital Medical University
        • Contact:
          • Yi Zhao
      • Beijing, Beijing, China
        • Beijing Luhe Hospital, Capital Medical University
        • Contact:
          • Baoyu Zhang
      • Beijing, Beijing, China
        • Aerospace Central Hospital
        • Contact:
          • Jian Liu
      • Beijing, Beijing, China
        • Beijing Shijingshan Hospital
        • Contact:
          • Lian'na Xu
      • Beijing, Beijing, China
        • Beijing Shunyi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Eldecalcitol
Participants receive oral eldecalcitol 0.75μg daily for 12 months
Drug: Eldecalcitol capsules
Oral eldecalcitol 0.75μg daily
Other Names:
  • Edirol
Active Comparator: Alfacalcidol + calcium carbonate
Participants receive oral calcitriol 0.5μg daily and 1.5g calcium carbonate daily for 12 months
Drug: Alfacalcidol tablets
Oral Alfacalcidol 0.5μg daily
Drug: Calcium carbonate tablets
1.5g Calcium carbonate daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD)
Time Frame: Baseline and 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent change from baseline to month 6 in lumbar spine (L1-4) BMD
Time Frame: Baseline and 6 months
BMD will be measured using DXA. Images will be analyzed by blinded independent central review.
Baseline and 6 months
Percent change from baseline in total hip BMD
Time Frame: Baseline, 6 months and 12 months
BMD will be measured using DXA. Images will be analyzed by blinded independent central review.
Baseline, 6 months and 12 months
Percent change from baseline in femoral neck BMD
Time Frame: Baseline, 6 months and 12 months
BMD will be measured using DXA. Images will be analyzed by blinded independent central review.
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)
Time Frame: Baseline and 12 months
Broadband ultrasound attenuation (BUA) and speed of sound (SOS) will be measured by quantitative ultrasound (QUS).
Baseline and 12 months
Percent change from baseline in Procollagen Type 1 N-telopeptide (P1NP)
Time Frame: Baseline, 6 months and 12 months
Serum P1NP will be tested
Baseline, 6 months and 12 months
Percent change from baseline in Type 1 Collagen C-telopeptide (CTX)
Time Frame: Baseline, 6 months and 12 months
Serum CTX will be tested
Baseline, 6 months and 12 months
Percentage of patients diagnosed with osteoporosis at month 12
Time Frame: Baseline and 12 months
Baseline and 12 months
Incidence of new vertebral fracture
Time Frame: Baseline and 12 months
New vertebral fracture will be confirmed by the lateral X-ray of thoracic/lumbar vertebrae
Baseline and 12 months
Change from baseline in Quality of Life assessed using EQ-5D-5L
Time Frame: Baseline, 6 months and 12 months
The EQ-5D-5L represents a global quality of life measure that includes multiple components potentially impacted by the anti-anginal treatments being examined. The EQ-5D-5L score includes questions on mobility, self-care, usual activities, anxiety/depression, and pain/discomfort on a 5-point scale: 1=No Problem, 2=Slight Problem, 3=Moderate Problem, 4=Severe Problem, 5=Extreme Problem or Inability. 0, 1, and negative values corresponding to death, full health, and health states worse than death, respectively. Higher scores indicated greater levels of problems across each of the five dimensions.
Baseline, 6 months and 12 months
Change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time Frame: Baseline, 6 months and 12 months
Physical function was assessed by HAQ-DI. It consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability.
Baseline, 6 months and 12 months
Change from baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score
Time Frame: Baseline, 6 months and 12 months
DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission.
Baseline, 6 months and 12 months
Percent change from baseline to month 12 in volumetric bone mineral density (vBMD) measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)
Time Frame: Baseline and 12 months
The vBMD includes several individual parameters as total volumetric bone mineral density (Tt.vBMD), trabecular volumetric bone density (Tb.vBMD), and cortical volumetric density (Ct.vBMD) which all in milligram/cubic centimetre.
Baseline and 12 months
Percent change from baseline to month 12 in bone microarchitecture measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)
Time Frame: Baseline and 12 months
The bone microarchitecture include several individual parameters as trabecular bone volume fraction (BV/TV) in %, trabecular number (Tb.N) in 1/millimeter, trabecular thickness (Tb.Th) in millimeter, trabecular separation (Tb.Sp) in millimeter, cortical thickness(Ct.Th) in millimeter, and cortical porosity (Ct.Po) in %.
Baseline and 12 months
Percent change from baseline to month 12 in bone geometry measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)
Time Frame: Baseline and 12 months
The bone geometry include several individual parameters as total bone cross-sectional area (Tt.Ar), cortical area (Ct.Ar), and trabecular area (Tb.Ar) which all in square millimeter.
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese SLE Treatment And Research Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Life oasis public service center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mengtao Li, MD, Peking Union Medical College Hospital
  • Principal Investigator: Weibo Xia, MD, Peking Union Medical College Hospital
  • Study Director: Ying Jiang, MD, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EDR-IIS-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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