Eldecalcitol vs Calcitriol for Postmenopausal Women with Low Bone Density

Comparison of the Efficacy and Safety With Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis

This study tests whether a new vitamin D treatment called eldecalcitol can help postmenopausal women with low bone density feel better than the standard treatment, calcitriol, over a year.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 50 Years and up
• Sex: Female
• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Academic / other)
• Locations: 21 sites (Changsha and 20 other locations)
• Trial ID: NCT05902078 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of eldecalcitol compared to calcitriol in postmenopausal women who have low bone mineral density or mild osteoporosis. Participants will be randomly assigned to receive either 0.75μg of eldecalcitol or 0.5μg of calcitriol daily for a duration of 12 months. The study aims to determine which treatment is more effective in improving bone health in this population. It is designed as an open-label, parallel controlled trial.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women aged 50 or older with low bone mineral density or mild osteoporosis.

Not a fit: Patients with severe vitamin D deficiency or certain endocrine disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for improving bone density in postmenopausal women.

How similar studies have performed: Other studies have shown promising results with similar treatments for osteoporosis, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Postmenopausal women (based on medical history) aged 50 or older and menopause time more than 2 years. If there is uncertainty regarding menopausal status, women 60 years 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 the following conditions at screening:

1\) low BMD: -2.5\<T\< -1.0, without vertebral and fragility fracture history 2) mild osteoporosis: T≤-2.5, without vertebral and fragility fracture history 3. Ambulatory outpatients 4. Written informed consent

Exclusion Criteria:

1. Severe vitamin D deficiency at screening (defined as serum 25OHD\<10 ng/ml);Vitamin D repletion will be permitted and dosage will be at the discretion of investigators and subjects may be re-screened
2. Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadal insufficiency, osteogenesis impotence, rheumatoid arthritis, poorly controlled diabetes mellitus (HbA1c\>9%), or other conditions that can cause secondary osteoporosis, 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 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 active vitamin D or selective estrogen receptor modulator or hormone replacement therapy or traditional Chinese medicine for bone pine within 2 months prior to study entry; 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\>400 mg/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 heart failure
7. Active malignant tumors or a history of malignant tumors within 5 years before informed consent obtained
8. History of allergy to vitamin D
9. Any condition which in the opinion of the investigator unfit for the study

Where this trial is running

Changsha and 20 other locations

• The Second Xiangya Hospital of Central South University — Changsha, China (Completed)
• Zhejiang Provincial People's Hospital — Hangzhou, China (Completed)
• The Fourth Affiliated Hospital of Harbin Medical University — Ha’erbin, China (Recruiting)
• 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)

Study contacts

• Principal investigator: Zhenlin Zhang — Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Study coordinator: Li Shen

Conditions Low Bone Mineral Density; Postmenopausal Osteoporosis