Clinical trial: Lifestyle Intervention to Improve Bone Quality (NCT03329963)

Eligibility criteria:
Inclusion Criteria:

          -  Age 65 - 85 years • BMI 30 - 40 kg/m2 • Stable body weight (±2 kg) during the past 6
             months • Sedentary (regular exercise <1 h/wk. or <2 x/wk. for the last 6 months) •
             Willing to provide informed consent

        Exclusion Criteria:

          -  Failure to provide informed consent.

          -  Any major chronic diseases, or any condition that would interfere with exercise or
             dietary restriction, in which exercise or dietary restrictions are contraindicated, or
             that would interfere with interpretation of results

          -  Cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke)
             or unstable disease (e.g., New York Heart Class III or IV congestive heart failure,
             severe pulmonary disease requiring steroid pills or the use of supplemental oxygen )
             that would contraindicate exercise or dietary restriction

          -  Severe orthopedic (e.g. awaiting joint replacement) and/or neuromuscular (e.g.
             multiple sclerosis, amyotrophic lateral sclerosis, active rheumatoid arthritis)
             disease or impairments that would contraindicate participation in exercise

          -  Other significant co-morbid disease that would impair ability to participate in the
             exercise-based intervention (e.g. renal failure on hemodialysis, severe psychiatric
             disorder [e.g. bipolar, schizophrenia], excess alcohol use [more than14 drinks per
             week])

          -  Severe visual or hearing impairments that would interfere with following directions

          -  Significant cognitive impairment, defined as a known diagnosis of dementia or positive
             screening test for dementia using the Mini-Mental State Exam score less than 24)

          -  Uncontrolled hypertension (BP>160/90 mm Hg)

          -  History of malignancy during the past 5 years (except non-melanoma skin cancers)

          -  Current use of bone acting drugs (e.g. use of estrogen, or androgen containing
             compound, raloxifene, calcitonin, parathyroid hormone during the past year or
             bisphosphonates during the last two years)

          -  Osteoporosis (T-score -2.5 and below on hip or spine scan) or history of fragility
             fractures - Diabetes mellitus requiring insulin for treatment or with a fasting blood
             glucose of >140 mg/dl, and/or HbA1c >8.5% (Those excluded from the study because of
             fasting blood glucose of >140 mg/dl or HbA1c>8.5% will be referred to their primary
             care provider for follow-up and appropriate treatment).

          -  Terminal illness with life expectancy less than 12 months, as determined by a
             physician

          -  Use of any drugs or natural products designed to induce weight loss within past three
             months.

          -  Positive exercise stress test for ischemia
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.
Subject must be at most 85 Years

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