Clinical trial: Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase (NCT02722980)

Eligibility criteria:
Inclusion Criteria:

        For inclusion in the study, subjects must fulfil the following criteria:

          1. Willing and able to give written informed consent for participation in the study.

          2. Healthy women in early post-menopausal phase (at least two [2] years but a maximum of
             12 years since the last menstruation and at least one [1] year since the last intake
             of hormone replacement therapy).

          3. BMI ≥ 18 and ≤ 30 at screening.

          4. BMD T-score in the lumbar spine (L1-L4) > -2.5, as measured by DXA.

          5. Commitment not to use any products that may influence the study outcome in the opinion
             of the Investigator.

          6. Ability to understand and comply with the requirements of the study, as judged by the
             Investigator.

        Exclusion Criteria:

        Subjects must not enter the study if any of the following exclusion criteria are fulfilled:

          1. Relevant history of >1 previous fracture after 50 years of age, as judged by the
             Investigator.

          2. T-score ≤ - 2.5, in the total hip or lumbar spine (L1-L4). These subjects should be
             forwarded to a GP for further investigation.

          3. History of metabolic bone disease.

          4. Unstable weight (± five [5] kg) during the last six (6) months.

          5. History of hyperthyroidism or unstable hypothyroidism.

          6. Diagnosed with disease causing secondary osteoporosis within the last year, including
             primary hyperparathyroidism, chronic obstructive pulmonary disease, inflammatory bowel
             disease (IBD), celiac disease or diabetes.

          7. Known history of rheumatoid arthritis, clinically significant kidney or heart disease,
             as judged by the Investigator.

          8. Gastric bypass surgery performed.

          9. History of immunodeficiency or immunosuppressive treatment.

         10. Chronic or acute diarrheal disease.

         11. Recently diagnosed malignancy (within the last five [5] years).

         12. Use of products containing probiotic bacteria (more than once per week) within four
             (4) weeks prior to baseline.

         13. Per-oral use of corticosteroids.

         14. Use of calcium and/or vitamin D supplements within one (1) month prior to baseline.

         15. Use of any anti-resorptive therapy, including e.g. systemic hormone replacement
             therapy, bisphosphonates (currently or during last 12 months)

         16. Use of any bone-formation stimulating therapy (currently or during the last 12
             months).

         17. Use of antibiotics during the last two (2) months.

         18. Frequent user of antibiotics (>2 courses during the last 12 months) due to
             inter-current infection episodes.

         19. Smoking or use of nicotine-containing products (currently or during the last six [6]
             months).

         20. History of alcohol abuse, or excessive intake of alcohol, as judged by the
             Investigator.

         21. Consumption of alcohol within 24 hours prior to the Baseline Visit.

         22. Participation in any other clinical interventional study during the last three (3)
             months.

         23. History of any clinically significant disease or disorder which, in the opinion of the
             Investigator, may either put the subject at risk because of participation in the
             study, or influence the results or the subject's ability to participate in the study

         24. Known hypersensitivity to any of the ingredients in the IP or the placebo
             (maltodextrin, silicon dioxide, capsule [hypromellose, water] ± bacterial culture).

         25. Blood or plasma donation within three (3) months prior to baseline.
Female
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 70 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