Clinical trial: Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076) (NCT01803607)

Eligibility criteria:
Inclusion Criteria:

          -  Postmenopausal for ≥5 years (defined as no menses for at least 5 years or at least 5
             years post bilateral oophorectomy).

          -  Prior or current treatment with oral bisphosphonate therapy (i.e., alendronate,
             risedronate, ibandronate) for postmenopausal osteoporosis for ≥3 years.

          -  BMD T-score at any hip site (femoral neck, trochanter, or total hip) ≤-2.5 and >-3.5
             as assessed by dual-energy X-ray absorptiometry (DXA) without a history of a prior
             fragility fracture. For participants with a history of a prior fragility fracture
             (except hip fracture), BMD T-score can be ≤-1.5 and >-3.5 at any hip site.

          -  Serum 25-hydroxyvitamin D level of ≥20 and ≤60 ng/mL within 90 days of the time of
             randomization.

        Exclusion Criteria:

          -  Evidence of a metabolic bone disorder other than osteopenia or osteoporosis

          -  History or current evidence of hip fracture.

          -  History of malignancy ≤5 years prior to signing informed consent, except for
             adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

          -  Active parathyroid disease. Participant with a documented history of parathyroid
             disease can be considered for inclusion if she has normal parathyroid hormone (PTH) at
             screening.

          -  History of thyroid disease not adequately controlled by medication.

          -  Current treatment with anti-seizure medication, with indices of calcium metabolism not
             within normal limits.

          -  Prior treatment with strontium-containing products; intravenous bisphosphonates;
             cathepsin K inhibitors; RANK ligand inhibitors; fluoride treatment at a dose greater
             than 1 mg/day for more than 2 weeks.

          -  Use of following medications within the 6 months prior to the screening visit:
             activated vitamin D; estrogen, with or without progestin, at a dose high enough to
             have systemic effects; raloxifene or other selective estrogen receptor modulator
             (SERM), tibolone or any aromatase inhibitor; sub-cutaneous calcitonin (Note: use of
             intranasal calcitonin is allowed at any time); anabolic steroid; PTH (1-34 or 1-84);
             growth hormone; systemic glucocorticoids (≥5 mg/day of prednisone or equivalent) for
             more than 2 weeks; cyclosporine for more than 2 weeks.

          -  Concurrent use of cancer chemotherapy or heparin; protease inhibitors for human
             immunodeficiency virus (HIV) treatment; and vitamin A (excluding beta carotene)
             >10,000 IU daily, unless willing to discontinue this dose during the study.

          -  Current treatment with cytochrome P450 3A4 (CYP3A4) inducers or treatment with CYP3A4
             inducer within 4 weeks of screening.
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