Clinical trial: Switching From Oral Bisphosphonates to Bazedoxifene to Evaluate Effects on Bone Mineral Density in Postmenopausal Women (NCT02090400)

Eligibility criteria:
Inclusion Criteria:

          -  Ambulatory postmenopausal women 55 years or older at screening

          -  Have received daily, weekly or monthly oral bisphosphonates at least for 3 years and
             treatment change is indicated (not responses to bisphosphonates, for bad tolerability
             or for the potential risk of side effects in a long term treatment with
             bisphosphonates-indicated by Federal Drug Administration, European Medicines Agency.

          -  Subjects has stop bisphosphonates therapy no more than one month before screening
             visit for subjects in daily or weekly bisphosphonates

          -  Subjects has stop bisphosphonates therapy no more than two months before screening
             visit for subjects in monthly bisphosphonates

          -  Screening T-score at the lumbar spine ≤ -2.0 to -4.0 by Dual X ray Absorptiometry
             (DXA) scan

          -  At least 2 lumbar vertebrae must be evaluable by DXA

          -  Al least one hip must be evaluable by DXA (for secondary objectives)

        Exclusion Criteria:

          -  Any disorder that compromises the ability of the subject to give written informed
             consent and/or to comply with study procedures

          -  Current use of medication prescribed for osteoporosis other than oral bisphosphonates

          -  Subjects who had received intravenous bisphosphonates or fluoride (except for dental
             treatment)

          -  Subjects who had received any Selective Estrogens Receptor Modulator (SERM), anabolic
             steroids, systemic hormone replacement, calcitonin or calcitriol within 3 months.

          -  Subjects who had received strontium ranelate, parathyroid hormone (PTH) or PTH
             derivates within 1 year.

          -  Hyper or hypothyroidism, current hyper or hypoparathyroidism

          -  History of Venous Thromboembolism Event (VTE)

          -  Significantly impaired renal function as determined by estimated Glomerular Filtration
             Rate less 35 mL/min

          -  Hyper or hypocalcemia

          -  Vitamin D deficiency (serum 25 (OH) vit D level < 20 ng/mL (< 50nmol/L)

          -  Any condition that could result in impaired calcium metabolism or metabolic bone
             disease that could interfere with interpretation findings
Female
Accepts Healthy Volunteers
Subject must be at least 55 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