Pomegranate Extract Biomarker Study in Osteopenic Women (NCT01219140) | Clinical Trial Compass
CompletedPhase 1
Pomegranate Extract Biomarker Study in Osteopenic Women
United States64 participantsStarted 2010-05
Plain-language summary
Treatment of post-menopausal subjects (with decreased bone mineral density) with pomegranate extract capsules will produce statistically significant changes in biomarkers for bone resorption and formation when compared to subjects receiving placebo.
Who can participate
Age range45 Years ā 65 Years
SexFEMALE
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Inclusion Criteria:
* Postmenopausal women (having had their last menstrual period within the past 15 years and an appropriate serum FSH value) 45-65 years of age;
* The subject must have a T score of -1 to -2.5 at the lumbar spine or proximal femur;
* All clinical safety laboratory values at screening and randomization must be either within the reference range or be determined by the investigator and the sponsor to be abnormal, but not clinically significant;
* The patient must have provided written informed consent.
Exclusion Criteria:
* The subject has any of the following conditions: connective tissue disease, history of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrinological, urological, immunological, neurologic or psychiatric disorders, unless approved by the sponsor on a case by case basis;
* The subject has a positive test result for Hepatitis B surface antigen or antibody to hepatitis C virus at Screening;
* The subject has a known history of infection with the human immunodeficiency virus (HIV); -
* The subject has used bisphosphonate or fluoride therapy within the past 12 or 24 months, respectively;
* The subject has used denosumab within the past 24 months;
* The subject has used tibolone, parathyroid hormone (or any of its derivatives), systemic glucocorticoids or inhaled glucocorticoids, anabolic steroids or testosterone within the past 6 months;
* The subject has used estā¦