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

Exclusion Criteria9

• 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