Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis (EFFECT)
Low Bone Mineral Density, Postmenopausal Osteoporosis
About this trial
This is an interventional treatment trial for Low Bone Mineral Density
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
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
Experimental
Active Comparator
Eldecalcitol
Calcitriol
Participants receive oral eldecalcitol 0.75μg daily for 12 months
Participants receive oral calcitriol 0.5μg daily for 12 months