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Rheumatoid ArthritisPhase 4ELEGANTNCT06385093

A Study on the Prevention and Treatment of GIOP With Eldecalcitol

A Phase 4 study testing Eldecalcitol capsules, Alfacalcidol tablets and Calcium carbonate tablets in people with Rheumatoid Arthritis and Osteoporosis, run by Chinese SLE Treatment And Research Group at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis, Osteoporosis, Osteopenia
What is being tested?
Eldecalcitol capsules, Alfacalcidol tablets and Calcium carbonate tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
7 sitesChina
Study dates
Jun 2024to Mar 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

Mengtao Li, MD contact

+86-10-69158793

mengtao.li@cstar.org.cn

Ying Jiang, MD contact

+86-13391701765

jiangying@pumch.cn

7 sites in 1 country

China7 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

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

  • Aerospace Central Hospital

    Beijing, Beijing Municipality

    Jian Liu

  • Beijing Luhe hospital, Capital Medical University

    Beijing, Beijing Municipality

    Baoyu Zhang

  • Beijing Shijingshan Hospital

    Beijing, Beijing Municipality

    Lian'na Xu

  • Beijing Shijitan Hospital

    Beijing, Beijing Municipality

    Yuhua Wang

  • Beijing Shunyi hospital

    Beijing, Beijing Municipality

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Yi Zhao

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Eldecalcitol capsules, Alfacalcidol tablets, Calcium carbonate tablets
Keywords
Rheumatoid Arthritis, Osteoporosis, Randomized Controlled Trial, Glucocorticoids, Eldecalcitol
Medical subject headings
Arthritis, Rheumatoid, Osteoporosis, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eldecalcitol capsulesDrug

    Also called Edirol

    Oral eldecalcitol 0.75μg daily

  • Alfacalcidol tabletsDrug

    Oral Alfacalcidol 0.5μg daily

  • Calcium carbonate tabletsDrug

    1.5g Calcium carbonate daily

Study groups in NCT06385093
Study groupRoleWhat they receive
EldecalcitolExperimentalParticipants receive oral eldecalcitol 0.75μg daily for 12 months
Receives: Drug: Eldecalcitol capsules
Alfacalcidol + calcium carbonateActive comparatorParticipants receive oral calcitriol 0.5μg daily and 1.5g calcium carbonate daily for 12 months
Receives: Drug: Alfacalcidol tablets; Drug: Calcium carbonate tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 12 months

Secondary outcomes (14)

  1. Percent change from baseline to month 6 in lumbar spine (L1-4) BMD

    BMD will be measured using DXA. Images will be analyzed by blinded independent central review.

    Measured: Baseline and 6 months

  2. Percent change from baseline in total hip BMD

    BMD will be measured using DXA. Images will be analyzed by blinded independent central review.

    Measured: Baseline, 6 months and 12 months

  3. Percent change from baseline in femoral neck BMD

    BMD will be measured using DXA. Images will be analyzed by blinded independent central review.

    Measured: Baseline, 6 months and 12 months

  4. Percent change from baseline to month 12 in broadband ultrasound attenuation (BUA) and speed of sound (SOS) measured by quantitative ultrasound (QUS)

    Broadband ultrasound attenuation (BUA) and speed of sound (SOS) will be measured by quantitative ultrasound (QUS).

    Measured: Baseline and 12 months

  5. Percent change from baseline in Procollagen Type 1 N-telopeptide (P1NP)

    Serum P1NP will be tested

    Measured: Baseline, 6 months and 12 months

  6. Percent change from baseline in Type 1 Collagen C-telopeptide (CTX)

    Serum CTX will be tested

    Measured: Baseline, 6 months and 12 months

  7. Percentage of patients diagnosed with osteoporosis at month 12

    Measured: Baseline and 12 months

  8. Incidence of new vertebral fracture

    New vertebral fracture will be confirmed by the lateral X-ray of thoracic/lumbar vertebrae

    Measured: Baseline and 12 months

  9. Change from baseline in Quality of Life assessed using EQ-5D-5L

    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.

    Measured: Baseline, 6 months and 12 months

  10. Change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)

    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.

    Measured: Baseline, 6 months and 12 months

  11. Change from baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score

    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.

    Measured: Baseline, 6 months and 12 months

  12. Percent change from baseline to month 12 in volumetric bone mineral density (vBMD) measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)

    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.

    Measured: Baseline and 12 months

  13. Percent change from baseline to month 12 in bone microarchitecture measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)

    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 %.

    Measured: Baseline and 12 months

  14. Percent change from baseline to month 12 in bone geometry measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)

    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.

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2024
  2. Study startJun 2024 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
314 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06385093
Sponsor's protocol ID
EDR-IIS-003
Acronym
ELEGANT
Status last verified
Apr 2024
First submitted
9 Apr 2024
Last updated
25 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Eldecalcitol capsules, Alfacalcidol tablets and Calcium carbonate tablets in people with Rheumatoid Arthritis and Osteoporosis, run by Chinese SLE Treatment And Research Group at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mengtao Li, MD (+86-10-69158793, mengtao.li@cstar.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD) (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06385093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.

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