Actively Recruiting
Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
Led by Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Updated on 2024-05-16
300
Participants Needed
21
Research Sites
113 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead Sponsor
C
Chugai Pharma China Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women aged 50 or older, with menopause for more than 2 years, or women 60 years and older if menopausal status is uncertain
- Low bone mineral density (T-score between -2.5 and -1.0) without vertebral or fragility fracture history
- Mild osteoporosis (T-score of -2.5 or lower) without vertebral or fragility fracture history
- Ambulatory outpatients
- Provided written informed consent
You will not qualify if you...
- Severe vitamin D deficiency at screening (serum 25OHD below 10 ng/ml); vitamin D repletion allowed with possible rescreening
- Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadal insufficiency, osteogenesis imperfecta, rheumatoid arthritis, poorly controlled diabetes (HbA1c >9%), or other causes of secondary osteoporosis
- Treatment with glucocorticoids within 2 months before study entry
- Bisphosphonate injections within 3 years, or oral bisphosphonate use for 6 months or more within 3 years before study entry
- Use of parathyroid hormone within 3 years before study entry
- Use of calcitonin, vitamin K, active vitamin D, selective estrogen receptor modulators, hormone replacement therapy, or traditional Chinese medicine for bone health within 2 months before study entry
- Prior treatment with subcutaneous anti-RANKL antibody
- Kidney stones at screening
- Hypercalcemia (serum calcium >10.4 mg/dL), hypercalciuria (urine calcium >400 mg/gCr), or hyperuricemia (above 360 μmol/L in women)
- Severe liver disease such as cirrhosis or serious heart disease such as severe heart failure
- Active malignant tumors or history of cancer within 5 years before consent
- Allergy to vitamin D
- Any condition deemed unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
The Second Xiangya Hospital of Central South University
Changsha, China
Completed
2
Zhejiang Provincial People's Hospital
Hangzhou, China
Completed
3
The Fourth Affiliated Hospital of Harbin Medical University
Ha’erbin, China
Actively Recruiting
4
Huai 'an First People's Hospital
Huai'an, China
Completed
5
Liaocheng People's Hospital
Liaocheng, China
Completed
6
Jiangxi Provincial People's Hospital
Nanchang, China
Completed
7
Jiangsu Geriatric Hospital
Nanjin, China
Completed
8
The First Hospital of Ningbo
Ningbo, China
Completed
9
The Sixth Hospital of Ningbo
Ningbo, China
Completed
10
Pingxiang People's Hospital
Pingxiang, China
Completed
11
Huadong Hospital Affiliated to Fudan University
Shanghai, China
Completed
12
Shanghai First People's Hospital
Shanghai, China
Completed
13
Shanghai Pudong New Area Punan Hospital
Shanghai, China
Completed
14
Shanghai Sixth People's Hospital
Shanghai, China
Completed
15
Zhongshan Hosiptal Affiliated to Fudan University
Shanghai, China
Completed
16
The Second Affiliated Hospital of Soochow University
Suzhou, China
Completed
17
The First Hospital of Shanxi Medical University
Taiyuan, China
Completed
18
The Second Hospital of Shanxi Medical University
Taiyuan, China
Completed
19
Tianjin Hospital
Tianjin, China
Completed
20
Xi'an Honghui Hospital
Xi'an, China
Completed
21
Xuzhou Central Hospital
Xuzhou, China
Completed
Research Team
L
Li Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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