Clinical trial: Preventing Osteoporosis Using Denosumab (NCT02753283)

Eligibility criteria:
Inclusion Criteria:

        Ambulatory male and female residents with osteoporosis or low bone mass (at risk for
        fracture) ages 65 and older will be considered if:

          -  Reside in long-term care institution (nursing home or assisted living facility); and

          -  HaveOsteoporosis: (1) by bone density [spine, hip or forearm Bone Mineral Density
             (BMD) T-score ≤ -2.5]; (2) A previous adult fragility fracture of the spine or hip; or
             (3) Would be treated based on FRAX® and the National Osteoporosis Foundation (NOF)
             treatment thresholds of a 10 year risk of ≥ 20% for a major fracture or ≥ 3% for hip
             fracture suing femoral neck BMD.

        Exclusion Criteria:

          -  Institutionalized residents with subacute illnesses who are not expected to survive or
             who will be discharged in < 2 years.

          -  Non-ambulatory residents (those who cannot stand and pivot with assistance in order to
             transfer to the DXA table).

          -  Those currently on therapy (including bisphosphonate, denosumab, or teriparatide) or
             who have been on a bisphosphonate for > 1year during the previous 2 years because some
             bisphosphonates are long acting.

          -  Those with a history of hypocalcemia or contraindication for treatment. We will screen
             for these conditions by detailed history, chart review, and baseline laboratory
             analyses.

          -  Those with vitamin D levels < 25ng/mL will be treated with vitamin D 50,000 IU/wk for
             8 weeks; they will be enrolled if the follow-up vitamin D level is 25 ng/mL or more
             (if after 2 rounds of vitamin D repletion their vitamin D level is not at least 25
             ng/mL, they will not be eligible to be randomized into the study).

          -  Those on dialysis or with stage 5 chronic kidney disease (eGFR<15ml/min) will be
             excluded at screening.

          -  Those requiring tooth extraction or oral surgery will not be enrolled until cleared by
             a dentist.

          -  Patients will be allowed to continue on glucocorticoids and anticonvulsants because
             their use is common in this population.

          -  Those on glucocorticoids and anticonvulsants will be allowed to continue in the study
             because their use is common in this population.

          -  Those on hormone replacement therapy (HRT), raloxifene, or prescribed protective hip
             pads by their Primary Care Physician (PCP) will be allowed to participate and continue
             on these therapies.

          -  We will suggest that participants stop long-term calcitonin as it has been
             discontinued in Europe due to cancer concerns.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 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