Clinical trial: An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women (NCT01796301)

Eligibility criteria:
Inclusion Criteria:

          -  Postmenopausal women, aged ≥ 55 to ≤ 90.

          -  Received oral bisphosphonate therapy for at least 3 years immediately prior to
             screening

          -  BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck

          -  History of nonvertebral fracture after age 50, or vertebral fracture.

        Exclusion Criteria:

          -  Use of other agents affecting bone metabolism including Strontium ranelate, fluoride
             (for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV
             bisphosphonates, denosumab, teriparatide (TPTD) or any parathyroid hormone (PTH)
             analogs, Systemic oral or transdermal estrogen, selective estrogen receptor modulators
             (SERMs), activated vitamin D3, vitamin K2, calcitonin, tibolone, cinacalcet, systemic
             glucocorticosteroids:

          -  History of metabolic or bone disease (except osteoporosis) that may interfere with the
             interpretation of study results, such as sclerosteosis, Paget's disease, rheumatoid
             arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing
             spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome.

          -  Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL, as determined
             by the central laboratory.

          -  Current hyper- or hypocalcemia

          -  Current, uncontrolled hyper- or hypothyroidism
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 90 Years

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