A Study of Amorphous Calcium Carbonate in Postmenopausal Women

Korábbi kezelés

• Subject on other osteoporosis therapies, parathyroid hormone or its derivatives, corticosteroids, systemic hormone-replacement therapy, selective estrogen-receptor modulators, tibolone, calcitonin or calcitriol 6 weeks prior to screening visit.
• Participation in any other investigational study within 30 days prior to receiving study medication.

Más betegség

• Subjects who had conditions that influence bone metabolism (i.e., Paget's disease and osteomalacia).
• Known hypersensitivity to any component of the study drug product.
• Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety.

Laborértékek

• Subjects had a serum 25-hydroxyvitamin D level of less than 12 ng/ml.

Egyéb

• Subjects had a BMD T-score of less than -4.0 at the lumbar spine or total hip.
• Subjects with any severe or more than two moderate vertebral fractures on spinal x-ray at screening visit.
• Subject who plan to initiate a new bisphosphonate treatment during study period.

• Postmenopausal women who are 60 to 90 years of age.
• With BMD T-score of lower than -2.5 at the lumbar spine or total hip and -4.0 or higher at both sites. Subject who also meet the following criteria:
  • A arm:-Subject who meet National Health Insurance (NHI) reimbursement criteria for use of denosumab.
  • B arm:-Subject who does not meet NHI reimbursement criteria for use of denosumab, or who is no willing to receive denosumab treatment during study period, even meet NHI reimbursement criteria.
• Subject who are naïve to osteoporosis treatment or have received prior bisphosphonate treatment for less than 3 years and not within 12 months prior to screening visit.
• A minimum of 2 evaluable lumbar vertebrae in the L1-L4 region and 1 evaluable hip (i.e., either the left or right side).
• Willingness to limit additional Vitamin D3 intake to 400IU or 800IU per day during the study period.
• Ability to complete the entire procedure and to comply with study instructions.
• Will provide completed and signed written informed consent.