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

NCT05902078 | Recruiting Phase 4

• 1 other identifier: 2023MDEDR0007
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Low Bone Mineral Density; Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine

  Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.

  Baseline to 12 months

Secondary Outcomes (10)

• Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine

  Baseline to 6 months

• Percent Change From Baseline at Month 6 in BMD of the Total Hip

  Baseline to 6 months

• Percent Change From Baseline at Month 6 in BMD of the Femoral Neck

  Baseline to 6 months

• Percent Change From Baseline at Month 12 in BMD of the Total Hip

  Baseline to 6 months

• Percent Change From Baseline at Month 12 in BMD of the Femoral Neck

  Baseline to 12 months

Study Arms (2)

Eldecalcitol

EXPERIMENTAL

Participants receive oral eldecalcitol 0.75μg daily for 12 months

Drug: Eldecalcitol capsules

Calcitriol

ACTIVE COMPARATOR

Participants receive oral calcitriol 0.5μg daily for 12 months

Drug: Calcitriol capsules

Interventions

Eldecalcitol capsules DRUG

Oral eldecalcitol 0.75μg daily

Also known as: Edirol

Eldecalcitol

Calcitriol capsules DRUG

Oral calcitriol 0.5μg daily

Also known as: Haidewei

Calcitriol

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• BMD (determined by DXA) of lumbar L1-4 or total hip or femoral neck met one of the following conditions at screening:
• \) 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

You may not qualify if:

• 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
• 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
• 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
• Urolithiasis at screening
• 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)
• Severe liver disease such as cirrhosis or serious heart disease such as severe heart failure
• Active malignant tumors or a history of malignant tumors within 5 years before informed consent obtained
• History of allergy to vitamin D
• Any condition which in the opinion of the investigator unfit for the study

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead
• Chugai Pharma China Co., Ltd.: collaborator

Study Sites (21)

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

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis, Postmenopausal

Interventions

eldecalcitol; Calcitriol

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Osteoporosis

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Zhenlin Zhang

  Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Shen

CONTACT

(+86)15800674978; shenli_0510@126.com

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: Chief Physician

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: September 27, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (21)