Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-meno… (NCT02722980) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase
Sweden249 participantsStarted 2016-04
Plain-language summary
The aim of the current study is to evaluate the efficacy of a probiotic product on bone mineral density (BMD) in healthy early post-menopausal women, compared to placebo. The primary endpoint is to assess changes of BMD at lumbar spine after an intervention period of 12 months. Changes in BMD at the femoral neck (hip) will also be measured as well as changes in bone turnover markers during the period of 12 months.
Who can participate
Age range45 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. Willing and able to give written informed consent for participation in the study.
✓. 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).
✓. BMI ≥ 18 and ≤ 30 at screening.
✓. BMD T-score in the lumbar spine (L1-L4) \> -2.5, as measured by DXA.
✓. Commitment not to use any products that may influence the study outcome in the opinion of the Investigator.
✓. Ability to understand and comply with the requirements of the study, as judged by the Investigator.
Exclusion criteria
✕. Relevant history of \>1 previous fracture after 50 years of age, as judged by the Investigator.
✕. T-score ≤ - 2.5, in the total hip or lumbar spine (L1-L4). These subjects should be forwarded to a GP for further investigation.
✕. History of metabolic bone disease.
✕. Unstable weight (± five \[5\] kg) during the last six (6) months.
✕. History of hyperthyroidism or unstable hypothyroidism.
✕. 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.
What they're measuring
1
Change in BMD at lumbar spine following an intervention period of 12 months and measured by DXA.
Timeframe: Change in BMD from baseline to 12 months