Clinical trial: Dried Plums and Bone Health in Postmenopausal Women (NCT02822378)

Eligibility criteria:
Inclusion Criteria:

          -  Postmenopausal women

          -  not severely obese (BMI < 40 kg/m2);

          -  healthy (determined by a screening questionnaire, complete metabolic panel);

          -  willing to include dried plums in their daily diet;

          -  not taking any natural dietary supplement containing phenolics, blueberries or apples
             for at least 2 months prior to study entry; can stop for 2 months to meet entry
             criteria

          -  non-smoking; ambulatory;

          -  low BMD as measured by dual energy X-ray absorptiometry (DXA). Eligible BMD values
             (T-scores) for DXA measures of the lumbar spine, total hip and/or femoral neck will
             correspond to T-scores between 0 and -3.0.

        Exclusion Criteria:

          -  Women who regularly consume dried plums, dried apples, prune juice, or heavy consumers
             of blueberries (1 cup or more/day). Potential volunteers who will refrain from
             consumption of the afore mentioned foods for the duration of the study will become
             eligible after a 2 month washout period;

          -  vitamin D deficiency (<20 ng/mL);

          -  history of vertebral fracture or fragility fracture of the wrist, humerus, hip or
             pelvis after age 50 yr);

          -  untreated hyper- or hypothyroidism;

          -  current hyper- or hypoparathyroidism;

          -  significantly impaired renal function; high potassium

          -  current hypo- or hypercalcemia;

          -  history of spinal stenosis;

          -  history of heart attack, stroke, thromboembolism, kidney disease, malabsorption
             syndrome, seizure disorders;

          -  positive for HIV, Hep-C or Hep-B surface antigen and malignancy.

          -  Use of the following agents affecting bone metabolism:

               -  intravenous bisphosphonates at any time;

               -  fluoride (for osteoporosis) within the past 24 months;

               -  denosumab at any time;

               -  bisphosphonates, parathyroid hormone or strontium within the past 12 months;

               -  calcitonin or selective estrogen receptor modulators within the past 12 months;

               -  systemic oral or transdermal estrogen within the past 3 months;

               -  systemic glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more than
                  10 days); or

               -  tibolone within the past 3 months.

          -  Participants who will not consume study therapy or will not stop taking natural
             product supplements of their own selection.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 75 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? Entailment