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Sponsored by: |
University of Messina |
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Information provided by: | University of Messina |
ClinicalTrials.gov Identifier: | NCT00541710 |
The purpose of this study is to determine whether the phytoestrogen genistein is effective in improving bone condition in pre-menopausal and post-menopausal women suffering for osteopenia. Since, during the study the investigators realized that at least 70% of post-menopausal recruited women suffered for metabolic syndrome, we have added only in these women, as secondary outcome measures, the evaluation of markers of cardiovascular risk.
Condition | Intervention | Phase |
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Osteoporosis Pre-Menopausal Osteopenia Post-Menopausal Osteopenia |
Drug: genistein Drug: A1 Drug: B1 Drug: C1 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 180 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
pre-menopausal osteopenic women
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Drug: genistein
pills of 27 mg, twice per day for 12 months, plus vit. D 400 IU and calcium 500 mg. pre-menopausal osteopenic women |
B: Active Comparator
early post-menopausal osteopenic women
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Drug: genistein
pills of 27 mg, twice per day for 12 months early post-menopausal osteopenic women |
C: Active Comparator
late-post-menopausal osteopenic women
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Drug: genistein
pills of 27 mg, twice per day for 12 months late-post-menopausal osteopenic women |
A1: Placebo Comparator
placebo pills containing calcium 500 mg and vit. D 400 IU
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Drug: A1
placebo pills containing calcium 500 mg and vit D 400 IU
|
B1: Placebo Comparator
placebo pills containing calcium 500 mg and vit D 400 IU
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Drug: B1
placebo pills containing calcium 500 mg and vit D 400 IU
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C1: Placebo Comparator
placebo pills containing calcium 500 mg and vit D 400 IU
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Drug: C1
placebo pills containing calcium 500 mg and vit. D 400 IU
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Ages Eligible for Study: | 45 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Silvia Russo, consultant | 0039 90 22155 | silvia_ergy@hotmail.com |
Italy | |
Azienda Policlinico Universitario, G. Martino | Recruiting |
Messina, Italy, 090 | |
Contact: Silvia Russo, consultant |
Principal Investigator: | Rosario D'Anna, professor | University of Messina, Italy |
Responsible Party: | University of Messina ( Rosario D'Anna, associate professor ) |
Study ID Numbers: | RODA-12254 |
Study First Received: | October 9, 2007 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00541710 History of Changes |
Health Authority: | Italy: Ethics Committee |
menopause genistein osteopenia osteoporosis prevention |
Anticarcinogenic Agents Estrogens Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Bone Diseases, Metabolic Protein Kinase Inhibitors |
Bone Diseases Hormones Calcium, Dietary Musculoskeletal Diseases Phytoestrogens Menopause Genistein |
Anticarcinogenic Agents Estrogens Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Enzyme Inhibitors Bone Diseases, Metabolic Protein Kinase Inhibitors |
Protective Agents Bone Diseases Hormones Pharmacologic Actions Musculoskeletal Diseases Estrogens, Non-Steroidal Therapeutic Uses Phytoestrogens Genistein |