Clinical trial: STEP: Study of Imaging Techniques (ImaTx and DXA) in Postmenopausal Women With OstEoporosis Using Preotact (FP-008-ES) (NCT00583518)

Eligibility criteria:
Inclusion Criteria:

          1. Has the subject given informed consent according to local requirements before any
             trial-related activities? A trial-related activity is any procedure that would not
             have been performed during the routine management of the subject.

          2. Is the subject a female?

          3. Is the subject 65 years old or above?

          4. Is the subject postmenopausal (more than 5 years), in the judgement of the
             investigator?

          5. Does the subject have primary osteoporosis, with a lumbar spine T score ≤ -3.0 SD, or
             a lumbar spine T-score ≤ -2.5 SD and previous fragility fracture[1], with a minimum of
             two evaluable lumbar vertebrae?

          6. Does the subject have a life expectancy of > 2 years?

          7. Does the subject have a clinical indication to receive PTH(1-84) and is able to
             self-inject (or to have PTH(1-84) injection by a helper)?

        All inclusion criteria must be answered "yes" for a subject to participate in the trial.

        [1] Definition of fragility fracture in the scope of the study: Bone fractures that occur
        as a result of a fall from standing height or less. That is, fractures resulting from
        mechanical forces that would not ordinarily cause fractures in a healthy person.

        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?

        All exclusion criteria must be answered "no" for a subject to participate in the trial.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Contradiction