Phase
Condition
Post-menopausal Osteopenia
Osteoporosis
Treatment
Calcitriol capsules
Eldecalcitol capsules
Clinical Study ID
Ages > 50 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Postmenopausal women (based on medical history) aged 50 or older and menopause timemore than 2 years. If there is uncertainty regarding menopausal status, women 60years 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 thefollowing conditions at screening:
- low BMD: -2.5<T< -1.0, without vertebral and fragility fracture history 2) mildosteoporosis: T≤-2.5, without vertebral and fragility fracture history 3. Ambulatoryoutpatients 4. Written informed consent
Exclusion
Exclusion Criteria:
Severe vitamin D deficiency at screening (defined as serum 25OHD<10 ng/ml);Vitamin Drepletion will be permitted and dosage will be at the discretion of investigatorsand subjects may be re-screened
Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadalinsufficiency, osteogenesis impotence, rheumatoid arthritis, poorly controlleddiabetes mellitus (HbA1c>9%), or other conditions that can cause secondaryosteoporosis, 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 priorto study entry; or had received parathyroid hormone once or more in the 3 yearsbefore entering the study; or received 2 weeks or more of calcitonin or vitamin K oractive vitamin D or selective estrogen receptor modulator or hormone replacementtherapy or traditional Chinese medicine for bone pine within 2 months prior to studyentry; 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>400mg/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 heartfailure
Active malignant tumors or a history of malignant tumors within 5 years beforeinformed consent obtained
History of allergy to vitamin D
Any condition which in the opinion of the investigator unfit for the study
Study Design
Study Description
Connect with a study center
The Second Xiangya Hospital of Central South University
Changsha,
ChinaCompleted
The Fourth Affiliated Hospital of Harbin Medical University
Ha'erbin,
ChinaActive - Recruiting
Zhejiang Provincial People's Hospital
Hangzhou,
ChinaCompleted
Huai 'an First People's Hospital
Huai'an,
ChinaCompleted
Liaocheng People's Hospital
Liaocheng,
ChinaCompleted
Jiangxi Provincial People's Hospital
Nanchang,
ChinaCompleted
Jiangsu Geriatric Hospital
Nanjin,
ChinaCompleted
The First Hospital of Ningbo
Ningbo,
ChinaCompleted
The Sixth Hospital of Ningbo
Ningbo,
ChinaCompleted
Pingxiang People's Hospital
Pingxiang,
ChinaCompleted
Huadong Hospital Affiliated to Fudan University
Shanghai,
ChinaCompleted
Shanghai First People's Hospital
Shanghai,
ChinaCompleted
Shanghai Pudong New Area Punan Hospital
Shanghai,
ChinaCompleted
Shanghai Sixth People's Hospital
Shanghai,
ChinaCompleted
Zhongshan Hosiptal Affiliated to Fudan University
Shanghai,
ChinaCompleted
The Second Affiliated Hospital of Soochow University
Suzhou,
ChinaCompleted
The First Hospital of Shanxi Medical University
Taiyuan,
ChinaCompleted
The Second Hospital of Shanxi Medical University
Taiyuan,
ChinaCompleted
Tianjin Hospital
Tianjin,
ChinaCompleted
Xi'an Honghui Hospital
Xi'an,
ChinaCompleted
Xuzhou Central Hospital
Xuzhou,
ChinaCompleted
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