STEP: Study of Imaging Techniques (ImaTx and DXA) in Postmenopausal Women With OstEoporosis Using Preotact (FP-008-ES)

Exclusion Criteria

• •1. Is the patient currently taking any of the following treatments: bisphosphonates, selective estrogen receptor modulators or hormone replacement therapy (if the patient discontinues any of these treatments at the screening visit, the question can be answered NO and the patient can be included)?
• •2. Has the subject received, during her lifetime, strontium, fluoride or calcitonin \> 3 months in total?
• •3. Has the subject ever been treated with teriparatide or PTH(1-84)?
• •4. Is the subject taking any other medication known to affect bone metabolism in the opinion of the investigator?
• •5. Has the subject ever received radiation therapy to the skeleton?
• •6. Has the subject ever been treated for a bone malignant disease?
• •7. Is the subject suffering from any known clinically significant diseases affecting calcium metabolism, including metabolic bone diseases such as hyperparathyroidism, Paget's disease, osteogenesis imperfecta, or osteomalacia?
• •8. Does the subject have any known history of hypersensitivity to parathyroid hormone or any of the excipients in the drug?
• •9. Does the subject have an elevated serum calcium (total serum calcium value \>10.2 mg/dl) after at least 14 days of a 1000 mg calcium and 800 IU vitamin D3 supplementation?
• •10. Does the subject have a clinically significant elevation of serum alkaline phosphatase judged by the investigator?
• •11. Does the subject have an impaired kidney function with creatinine clearance \<30ml/min (indirect measurement by serum creatinine)?
• •12. Does the subject have a severe hepatic impairment, defined as \> 9 Child-Pugh score?
• •13. Has the subject participated in a clinical trial with an Investigational Medicinal Product (IMP) during the last 30 days?
• •14. Does the subject have a bilateral hip replacement?