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

Primary Purpose

Low Bone Mineral Density, Postmenopausal Osteoporosis

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Eldecalcitol capsules
Calcitriol capsules
Sponsored by
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Bone Mineral Density

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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: 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: 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

Sites / Locations

  • The Second Xiangya Hospital of Central South University
  • The Fourth Affiliated Hospital of Harbin Medical University
  • Zhejiang Provincial People's Hospital
  • Huai 'an First People's Hospital
  • Liaocheng People's Hospital
  • Jiangxi Provincial People's Hospital
  • Jiangsu Geriatric Hospital
  • The First Hospital of Ningbo
  • The Sixth Hospital of Ningbo
  • Pingxiang People's Hospital
  • Huadong Hospital Affiliated to Fudan University
  • Shanghai First People's Hospital
  • Shanghai Pudong New Area Punan Hospital
  • Shanghai Sixth People's Hospital
  • Zhongshan Hosiptal Affiliated to Fudan University
  • The Second Affiliated Hospital of Soochow University
  • The First Hospital of Shanxi Medical University
  • The Second Hospital of Shanxi Medical University
  • Tianjin Hospital
  • Xi'an Honghui Hospital
  • Xuzhou Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eldecalcitol

Calcitriol

Arm Description

Participants receive oral eldecalcitol 0.75μg daily for 12 months

Participants receive oral calcitriol 0.5μg daily for 12 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Serum P1NP will be determined
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Serum CTX will be determined
Percent Change From Baseline in Parathyroid Hormone (PTH)
Serum PTH will be determined
Percent Change From Baseline in 25-Hydroxyvitamin D [25(OH)D]
Serum 25(OH)D will be determined
Incidence of new vertebral fracture
New vertebral fracture will be confirmed by the lateral X-ray of thoracic/lumbar vertebrae

Full Information

First Posted
June 5, 2023
Last Updated
June 5, 2023
Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborators
Chugai Pharma China Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05902078
Brief Title
Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
Acronym
EFFECT
Official Title
Comparison of the Efficacy and Safety With Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborators
Chugai Pharma China Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Bone Mineral Density, Postmenopausal Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eldecalcitol
Arm Type
Experimental
Arm Description
Participants receive oral eldecalcitol 0.75μg daily for 12 months
Arm Title
Calcitriol
Arm Type
Active Comparator
Arm Description
Participants receive oral calcitriol 0.5μg daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Eldecalcitol capsules
Other Intervention Name(s)
Edirol
Intervention Description
Oral eldecalcitol 0.75μg daily
Intervention Type
Drug
Intervention Name(s)
Calcitriol capsules
Other Intervention Name(s)
Haidewei
Intervention Description
Oral calcitriol 0.5μg daily
Primary Outcome Measure Information:
Title
Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine
Description
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine
Description
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Time Frame
Baseline to 6 months
Title
Percent Change From Baseline at Month 6 in BMD of the Total Hip
Description
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Time Frame
Baseline to 6 months
Title
Percent Change From Baseline at Month 6 in BMD of the Femoral Neck
Description
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Time Frame
Baseline to 6 months
Title
Percent Change From Baseline at Month 12 in BMD of the Total Hip
Description
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Time Frame
Baseline to 6 months
Title
Percent Change From Baseline at Month 12 in BMD of the Femoral Neck
Description
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Time Frame
Baseline to 12 months
Title
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Description
Serum P1NP will be determined
Time Frame
Baseline and months 6 and 12
Title
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Description
Serum CTX will be determined
Time Frame
Baseline and months 6 and 12
Title
Percent Change From Baseline in Parathyroid Hormone (PTH)
Description
Serum PTH will be determined
Time Frame
Baseline and months 6 and 12
Title
Percent Change From Baseline in 25-Hydroxyvitamin D [25(OH)D]
Description
Serum 25(OH)D will be determined
Time Frame
Baseline and months 6 and 12
Title
Incidence of new vertebral fracture
Description
New vertebral fracture will be confirmed by the lateral X-ray of thoracic/lumbar vertebrae
Time Frame
Baseline and months 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Shen
Phone
(+86)15800674978
Email
shenli_0510@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenlin Zhang
Organizational Affiliation
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongjian Xie
First Name & Middle Initial & Last Name & Degree
Zhongjian Xie
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Ha'erbin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhifeng Cheng
First Name & Middle Initial & Last Name & Degree
Zhifeng Cheng
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qifeng Ying
First Name & Middle Initial & Last Name & Degree
Qifeng Ying
Facility Name
Huai 'an First People's Hospital
City
Huai'an
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Mao
First Name & Middle Initial & Last Name & Degree
Li Mao
Facility Name
Liaocheng People's Hospital
City
Liaocheng
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Bai
First Name & Middle Initial & Last Name & Degree
Jie Bai
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanan Huo
First Name & Middle Initial & Last Name & Degree
Yanan Huo
Facility Name
Jiangsu Geriatric Hospital
City
Nanjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Ouyang
First Name & Middle Initial & Last Name & Degree
Xiaojun Ouyang
Facility Name
The First Hospital of Ningbo
City
Ningbo
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Yao
First Name & Middle Initial & Last Name & Degree
Qi Yao
Facility Name
The Sixth Hospital of Ningbo
City
Ningbo
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Na Wang
First Name & Middle Initial & Last Name & Degree
Na Wang
Facility Name
Pingxiang People's Hospital
City
Pingxiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yawei Zhang
First Name & Middle Initial & Last Name & Degree
Yawei Zhang
Facility Name
Huadong Hospital Affiliated to Fudan University
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Cheng
First Name & Middle Initial & Last Name & Degree
Qun Cheng
Facility Name
Shanghai First People's Hospital
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li You
First Name & Middle Initial & Last Name & Degree
Li You
Facility Name
Shanghai Pudong New Area Punan Hospital
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianyong Liu
First Name & Middle Initial & Last Name & Degree
Lianyong Liu
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenlin Zhang
First Name & Middle Initial & Last Name & Degree
Zhenlin Zhang
Facility Name
Zhongshan Hosiptal Affiliated to Fudan University
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Hu
First Name & Middle Initial & Last Name & Degree
Yu Hu
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youjia Xu
First Name & Middle Initial & Last Name & Degree
Youjia Xu
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Gao
First Name & Middle Initial & Last Name & Degree
Fei Gao
Facility Name
The Second Hospital of Shanxi Medical University
City
Taiyuan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yikun Zhu
First Name & Middle Initial & Last Name & Degree
Yikun Zhu
Facility Name
Tianjin Hospital
City
Tianjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aijun Chao
First Name & Middle Initial & Last Name & Degree
Aijun Chao
Facility Name
Xi'an Honghui Hospital
City
Xi'an
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuhong Zeng
First Name & Middle Initial & Last Name & Degree
Yuhong Zeng
Facility Name
Xuzhou Central Hospital
City
Xuzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cunzhi Lu
First Name & Middle Initial & Last Name & Degree
Cunzhi Lu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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