Clinical trial: µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis (NCT01153425)

Eligibility criteria:
Inclusion Criteria:

          -  Women

          -  Age ≥ 60 years

          -  Bone mineral density T-score of either the spine (L1-L4), total hip or femoral neck of
             ≤ - 2.0, or has a history of an osteoporotic fracture

        Exclusion Criteria:

          -  Previous treatment with pamidronate, ibandronate, of more than 2 doses in 2 years and
             of zoledronic acid at any time

          -  Previous treatment with teriparatide, alendronate or risedronate of more than 2 months
             in the last 24 months

          -  Previous treatment with calcitonin within the previous year; previous treatment with
             an estrogen or selective estrogen modulator will not exclude a potential subject
             unless she has been taking it for < 1 year (a woman who discontinued estrogen or a
             selective estrogen receptor within the previous year will also be excluded)

          -  Other diseases known to affect bone, such as Paget's disease, Cushing's disease,
             hyperthyroidism, hyperparathyroidism, bone cancer and metastases to bone, and vitamin
             D deficiency

          -  Medications known to affect bone, such as anticonvulsants, high dose glucocorticoids
             (20 mg/day or more > 2 weeks within the previous 6 months)

          -  Current alcohol use > 3 drinks/day

          -  Untreated or unstable cardiac, pulmonary, liver (SGOT > 2X upper limit of normal) or
             renal disease (creatinine > 1.2 mg/dL) or uncontrolled diabetes (hemoglobin A1C > 8.0)

          -  Prior radiation therapy to the skeleton

          -  Cardiac pacemakers, ferromagnetic implants or brain aneurysm clips

          -  Claustrophobia

          -  Subjects whose initial MRI is of poor quality due to motion artifact will be asked to
             repeat the examination; if a repeat MRI is of poor quality due to motion artifact, the
             subject will be excluded from the study

          -  Abnormalities of the which delay esophageal emptying such as stricture or achalasia

          -  Inability to stand or sit upright for at least 30 minutes

          -  Hypocalcemia

          -  Uric acid level >7.5ml/dl

          -  Subjects with metallic objects in their bodies
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 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