A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis

Exclusion Criteria

• •History of an osteoporotic fracture, defined as a fracture at the wrist, hip, or humerus occurring from a fall at standing height or less.
• •BMD T-Score at any site ≤ -2.5.
• •Current treatment (or within 3 months prior to randomization) with hormone replacement therapy.
• •History of metabolic and other bone diseases, including osteogenesis imperfecta, osteomalacia, and Paget's disease.
• •Vitamin D insufficiency defined as a 25 hydroxyvitamin D level \< 20 ng/mL (50 nmol/L).
• •Prior use of calcitonin, ever.
• •Prior use of any bisphosphonate, ever.
• •Prior use of denosumab, fluoride, or strontium, ever.
• •Prior use of parathyroid hormone analogs, ever.
• •Any condition or disease that may interfere with the ability to have a dual energy x-ray absorptiometry (DXA) scan or to evaluate a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion, pedicle screws, history of vertebroplasty, or degenerative disease that results in insufficient number of evaluable lumbar vertebrae, bilateral hip replacements.
• •Use of anabolic steroids or androgens within 6 months preceding randomization.
• •Use of vitamin D metabolites and analogs, (e.g., calcitriol) within 3 months preceding randomization). Note: Vitamin D supplementation is not exclusionary.
• •Use of estrogen or estrogen-related drugs (including selective estrogen receptor molecules), for example, tamoxifen, tibolone, or raloxifene within 3 months preceding randomization.
• •Chronic systemic treatment with glucocorticoids.
• •Clinically relevant abnormal history, physical findings, or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the subject.
• •Presence of acute or chronic illness or history of chronic illness which, in the judgment of the investigator, makes participation in the study medically inappropriate.
• •Known acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) seropositivity.
• •Uncontrolled hypertension, significant gastrointestinal abnormalities, uncontrolled diabetes mellitus, significant coronary heart disease, any psychotic mental illness, chronic allergic rhinitis, asthma, uncorrected endocrine dysfunction, or significantly impaired hepatic, respiratory, or renal function.
• •Participation in any other clinical study within the previous month.
• •History of drug or alcohol abuse, or intake of more than 30 units of alcohol weekly.
• •Possibility that the subject will not cooperate with the requirements of the protocol.
• •Known sensitivity to sCT.
• •Shift workers-individuals who are at work during overnight hours.