Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis

Last updated: May 15, 2024
Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Post-menopausal Osteopenia

Osteoporosis

Treatment

Calcitriol capsules

Eldecalcitol capsules

Clinical Study ID

NCT05902078
2023MDEDR0007
  • Ages > 50
  • Female

Study Summary

To investigate the efficacy and safety of eldecalcitol in postmenopausal women with low bone mineral density (BMD) or mild osteoporosis through a randomized, open-label, parallel controlled trial with calcitriol as the control.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Postmenopausal women (based on medical history) aged 50 or older and menopause timemore than 2 years. If there is uncertainty regarding menopausal status, women 60years of age and older will be considered postmenopausal.

  2. BMD (determined by DXA) of lumbar L1-4 or total hip or femoral neck met one of thefollowing conditions at screening:

  1. low BMD: -2.5<T< -1.0, without vertebral and fragility fracture history 2) mildosteoporosis: T≤-2.5, without vertebral and fragility fracture history 3. Ambulatoryoutpatients 4. Written informed consent

Exclusion

Exclusion Criteria:

  1. Severe vitamin D deficiency at screening (defined as serum 25OHD<10 ng/ml);Vitamin Drepletion will be permitted and dosage will be at the discretion of investigatorsand subjects may be re-screened

  2. Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadalinsufficiency, osteogenesis impotence, rheumatoid arthritis, poorly controlleddiabetes mellitus (HbA1c>9%), or other conditions that can cause secondaryosteoporosis, or treatment with glucocorticoids in the 2 months prior to study entry

  3. Had injected bisphosphonate once or more within 3 years before entering the study;or had received oral bisphosphonate oral for 6 months or more in the 3 years priorto study entry; or had received parathyroid hormone once or more in the 3 yearsbefore entering the study; or received 2 weeks or more of calcitonin or vitamin K oractive vitamin D or selective estrogen receptor modulator or hormone replacementtherapy or traditional Chinese medicine for bone pine within 2 months prior to studyentry; or received subcutaneous anti-RANKL antibody at any time prior to study entry

  4. Urolithiasis at screening

  5. Hypercalcemia (serum calcium >10.4 mg/dL), or hypercalciuria (urine calcium>400mg/gCr), or hyperuricemia (above 420 μmol/L in men and 360 μmol/L in women)

  6. Severe liver disease such as cirrhosis or serious heart disease such as severe heartfailure

  7. Active malignant tumors or a history of malignant tumors within 5 years beforeinformed consent obtained

  8. History of allergy to vitamin D

  9. Any condition which in the opinion of the investigator unfit for the study

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Calcitriol capsules
Phase: 4
Study Start date:
September 27, 2023
Estimated Completion Date:
December 31, 2025

Study Description

Postmenopausal women with low bone mineral density (BMD) or mild osteoporosis will be randomized in a 1:1 ratio to receive open-label oral 0.75μg eldecalcit daily or open-label oral 0.5μg calcitriol daily for 12 months.

Connect with a study center

  • The Second Xiangya Hospital of Central South University

    Changsha,
    China

    Completed

  • The Fourth Affiliated Hospital of Harbin Medical University

    Ha'erbin,
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou,
    China

    Completed

  • Huai 'an First People's Hospital

    Huai'an,
    China

    Completed

  • Liaocheng People's Hospital

    Liaocheng,
    China

    Completed

  • Jiangxi Provincial People's Hospital

    Nanchang,
    China

    Completed

  • Jiangsu Geriatric Hospital

    Nanjin,
    China

    Completed

  • The First Hospital of Ningbo

    Ningbo,
    China

    Completed

  • The Sixth Hospital of Ningbo

    Ningbo,
    China

    Completed

  • Pingxiang People's Hospital

    Pingxiang,
    China

    Completed

  • Huadong Hospital Affiliated to Fudan University

    Shanghai,
    China

    Completed

  • Shanghai First People's Hospital

    Shanghai,
    China

    Completed

  • Shanghai Pudong New Area Punan Hospital

    Shanghai,
    China

    Completed

  • Shanghai Sixth People's Hospital

    Shanghai,
    China

    Completed

  • Zhongshan Hosiptal Affiliated to Fudan University

    Shanghai,
    China

    Completed

  • The Second Affiliated Hospital of Soochow University

    Suzhou,
    China

    Completed

  • The First Hospital of Shanxi Medical University

    Taiyuan,
    China

    Completed

  • The Second Hospital of Shanxi Medical University

    Taiyuan,
    China

    Completed

  • Tianjin Hospital

    Tianjin,
    China

    Completed

  • Xi'an Honghui Hospital

    Xi'an,
    China

    Completed

  • Xuzhou Central Hospital

    Xuzhou,
    China

    Completed

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