Comparison of the Efficacy and Safety With Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
The Second Xiangya Hospital of Central South University
COMPLETED
Changsha
The Fourth Affiliated Hospital of Harbin Medical University
RECRUITING
Ha’erbin
Zhejiang Provincial People's Hospital
COMPLETED
Hangzhou
Huai 'an First People's Hospital
COMPLETED
Huai'an
Liaocheng People's Hospital
COMPLETED
Liaocheng
Jiangxi Provincial People's Hospital
COMPLETED
Nanchang
Jiangsu Geriatric Hospital
COMPLETED
Nanjin
The First Hospital of Ningbo
COMPLETED
Ningbo
The Sixth Hospital of Ningbo
COMPLETED
Ningbo
Pingxiang People's Hospital
COMPLETED
Pingxiang
Huadong Hospital Affiliated to Fudan University
COMPLETED
Shanghai
Shanghai First People's Hospital
COMPLETED
Shanghai
Shanghai Pudong New Area Punan Hospital
COMPLETED
Shanghai
Shanghai Sixth People's Hospital
COMPLETED
Shanghai
Zhongshan Hosiptal Affiliated to Fudan University
COMPLETED
Shanghai
The Second Affiliated Hospital of Soochow University
COMPLETED
Suzhou
The First Hospital of Shanxi Medical University
COMPLETED
Taiyuan
The Second Hospital of Shanxi Medical University
COMPLETED
Taiyuan
Tianjin Hospital
COMPLETED
Tianjin
Xi'an Honghui Hospital
COMPLETED
Xi'an
Xuzhou Central Hospital
COMPLETED
Xuzhou
Contact Information
Primary
Li Shen
shenli_0510@126.com
(+86)15800674978
Time Frame
Start Date:2023-09-27
Estimated Completion Date:2025-12
Participants
Target number of participants:300
Treatments
Experimental: Eldecalcitol
Participants receive oral eldecalcitol 0.75μg daily for 12 months
Active_comparator: Calcitriol
Participants receive oral calcitriol 0.5μg daily for 12 months