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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postmenopausal Osteoporosis; Low Bone Mineral Density
• Intervention / Treatment: Drug: Eldecalcitol capsules; Drug: Calcitriol capsules

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Li Shen; Phone Number: (+86)15800674978; Email: shenli_0510@126.com

Study Locations

• China
  • Changsha, China
    • Completed
    • The second Xiangya hospital of central south university
  • Ha'erbin, China
    • Recruiting
    • The Fourth Affiliated Hospital of Harbin Medical University
    • Principal Investigator: ZhiFeng Cheng
    • Contact: Zhifeng Cheng
  • Hangzhou, China
    • Completed
    • Zhejiang Provincial People's Hospital
  • Huai'an, China
    • Completed
    • Huai 'an First People's Hospital
  • Liaocheng, China
    • Completed
    • Liaocheng People's Hospital
  • Nanchang, China
    • Completed
    • Jiangxi Provincial People's Hospital
  • Nanjin, China
    • Completed
    • Jiangsu Geriatric Hospital
  • Ningbo, China
    • Completed
    • The First Hospital of Ningbo
  • Ningbo, China
    • Completed
    • The Sixth Hospital of Ningbo
  • Pingxiang, China
    • Completed
    • Pingxiang People's Hospital
  • Shanghai, 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
  • Suzhou, China
    • Completed
    • The Second Affiliated Hospital of Soochow University
  • Taiyuan, China
    • Completed
    • The First Hospital of Shanxi Medical University
  • Taiyuan, China
    • Completed
    • The Second Hospital of Shanxi Medical University
  • Tianjin, China
    • Completed
    • Tianjin Hospital
  • Xi'an, China
    • Completed
    • Xi'an Honghui Hospital
  • Xuzhou, China
    • Completed
    • Xuzhou Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Calcitriol; Participants receive oral calcitriol 0.5μg daily for 12 months	Drug: Calcitriol capsules; Oral calcitriol 0.5μg daily; Other Names: Haidewei

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline at Month 6 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 6 months
Percent Change From Baseline at Month 6 in BMD of the Total Hip	Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.	Baseline to 6 months
Percent Change From Baseline at Month 6 in BMD of the Femoral Neck	Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.	Baseline to 6 months
Percent Change From Baseline at Month 12 in BMD of the Total Hip	Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.	Baseline to 6 months
Percent Change From Baseline at Month 12 in BMD of the Femoral Neck	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
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)	Serum P1NP will be determined	Baseline and months 6 and 12
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)	Serum CTX will be determined	Baseline and months 6 and 12
Percent Change From Baseline in Parathyroid Hormone (PTH)	Serum PTH will be determined	Baseline and months 6 and 12
Percent Change From Baseline in 25-Hydroxyvitamin D [25(OH)D]	Serum 25(OH)D will be determined	Baseline and months 6 and 12
Incidence of new vertebral fracture	New vertebral fracture will be confirmed by the lateral X-ray of thoracic/lumbar vertebrae	Baseline and months 12

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Collaborators: Chugai Pharma China Co., Ltd.
• Investigators: Principal Investigator: Zhenlin Zhang, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Calcitriol; Eldecalcitol
• Other Study ID Numbers: 2023MDEDR0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No