Clinical trial: Zoledronic Acid for Osteoporosis in the Elderly (NCT00558012)

Eligibility criteria:
Inclusion Criteria:

          -  We will include elderly women 65 years and older if they reside in a nursing home or
             an assisted living facility and have a known history of osteoporosis, as determined by
             history of an adult fragility fracture or bone mineral density criteria for
             osteoporosis (T-score -2.5 at the total hip, femoral neck or spine) or low bone mass
             (T-score < -2.0 at the total hip, femoral neck or spine, consistent with the National
             Osteoporosis Foundation Treatment guidelines). If a participant's spine and or hip are
             not evaluable (due to surgery, calcifications, artifact in the scan area, scoliosis,
             etc.), they may be included in the study with a T-score of ≤ -2.0 at the forearm.

          -  Elders will be chosen without consideration of ethnic or racial background. We chose
             frail, institutionalized women because 70-85% of them have osteoporosis and this age
             group is substantially under-treated.

          -  We will include all who qualify, if they are able to weight bear or assist with
             transfer to chair, to endure that the results have maximum generalizability to the
             nursing home population as a whole.

        Exclusion Criteria:

          -  Children will be excluded because they are not frail, institutionalized elders.

          -  Men will be excluded because they do not become postmenopausal and are less likely to
             become osteoporotic.

          -  We will exclude institutionalized women with subacute illnesses who are not expected
             to survive or who will be discharged in less than 2 years.

          -  We will also exclude patient with a contraindication to bisphosphonate, such as
             hypocalcemia, allergy, pervious adverse event (excluding gastrointestinal disorders),
             or currently on an oral bisphosphonate.

          -  We will exclude patients with a calculated creatinine clearance of < 30 ml/mm.

          -  We will exclude women scheduled for or in need of a tooth extraction as this procedure
             has been associated with osteonecrosis of the jaw in patients with cancer given
             multiple coursed of high dose intravenous bisphosphonates.

          -  We will screen for these conditions by detailed history, physical exam (including
             dental exam), chart review, and baseline laboratory analyses, including
             BUN/creatinine, liver function tests, TSH, calcium, PTH, 25-hydroxyvitamin D, alkaline
             phosphatase and baseline calculated creatinine clearance. Participants with vitamin D
             levels < 20 ng/ml will be treated with vitamin D 50,000 IU/wk for 8 weeks in addition
             to calcium. Vitamin D will be rechecked and the patient will be enrolled if the
             vitamin D level is > 20 ng/ml.

          -  Patients will be allowed to continue on certain medications known to affect bone and
             mineral metabolism (e.g. glucocorticoids, anticonvulsants) because their use is common
             in this population. (In our facilities, 2.9% of patients use glucocorticoids and 7.2%
             use anti-epileptic drugs.) In addition, women who have been treated in the past or
             present with osteoporosis agents, such as estrogen/progesterone, raloxifene, and
             calcitonin, will be allowed to participate and continue on these therapies if
             prescribed by their physician. However, if patients are currently on or have been on
             bisphosphonates for greater than 1 year in the previous 2 years prior to enrollment,
             they will be excluded as some bisphosphonates are long acting.

          -  Patients will be allowed to wear hip pads if prescribed by their physician. If they
             are on parathyroid hormone, they may participate, but will be told that monotherapy
             with parathyroid hormone is more beneficial than combination therapy with parathyroid
             hormone and alendronate, as we have previously demonstrated.
Female
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