NCT03699150|Completed
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Sponsor study identifier
observational
1,100
0 countries
N/A
Study Start
June 22, 2012
Actual (reported)Primary Completion
December 31, 2017
Actual (reported)Study Completion
December 31, 2017
Actual (reported)Background: It is well known that health risks change during lifespan. The weight of a single risk factor increases with aging. The clinical significance of a single risk factor is clear but there is a lack on the effectof multiple risk factors linked together along different hormones condition of women's life in particular regarding to metabolic syndrome, osteoporosis, and thromboembolic risk. Aim: 1) characterization and follow up of cardiometabolic risk in women of childbearing age; 2) characterization and follow up of cardiometabolic risk and osteoporosis in menopausal-transition women and in post-menopausal women;
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 22, 2012
Actual (reported)December 31, 2017
Actual (reported)December 31, 2017
Actual (reported)September 7, 2018
Actual (reported)October 9, 2018
Actual (reported)Effects of different contraceptive therapies on change of insulin sensitivity, lipidemic and inflammatory profile, coagulation and anthropometric parameters in fertile age women
For each patient are collected data about: Oral glucose test tolerance (OGTT) with measures of glycemia (mg/dL) and insulinaemia (uU/mL) performed 7 times in 3 hours to obtain measure of insulin sensitivity (Matzuda-Index, OGIS Oral Glucose Insulin Sensitivity Index: (mL/min\*m2)
Each patient is evaluated at t=0 (baseline) and after 3 months (t=1). To verify the permanence of change during also the follow up the same measures are repeated at 12 (T=2) months and then once a year (t=3, t=4) (when necessary)
Effects of HRT and metabolic treatments on change of insulin sensitivity, lipidemic and inflammatory profile, coagulation, anthropometric parameters in menopausal transition and postmenopausal women.
Each patient is evaluated at t=0 (baseline) and after 3 months (t=1). To verify the permanence of change during also the follow up the same measures are repeated at 12 (T=2) months and then once a year (t=3, t=4) (when necessary)
Effects of "bone therapies" on change of bone mineral density (BMD) in menopausal transition and post-menopausal women
Each patient is evaluated at t=0 (baseline) and after 3 months (t=1). To verify the permanence of change during also the follow up the same measures are repeated at 12 (T=2) months and then once a year (t=3, t=4) (when necessary)
Effects of "bone therapies" on change of T-score in menopausal transition and post-menopausal women
Each patient is evaluated at t=0 (baseline) and after 3 months (t=1). To verify the permanence of change during also the follow up the same measures are repeated at 12 (T=2) months and then once a year (t=3, t=4) (when necessary)
Effects of "bone therapies" on change of Blood-markers of bone metabolism in menopausal transition and post-menopausal women
Each patient is evaluated at t=0 (baseline) and after 3 months (t=1). To verify the permanence of change during also the follow up the same measures are repeated at 12 (T=2) months and then once a year (t=3, t=4) (when necessary)
Outpatients referred to the Gynecologic Endocrinology, FTGM
Outpatients referred to the Gynecologic Endocrinology and Osteoporosis Unit of Fondazione CNR-Regione Toscana G. Monasterio, Pisa, Italy.
Maffei S, Formica A, Corsini D, Franchini M. Long-term effects of ospemifene on densitometric and bone metabolism biomarkers in postmenopausal women reporting Vulvar and Vaginal Atrophy (VVA). BMC Womens Health. 2026 Apr 28;26(1):296. doi: 10.1186/s12905-026-04474-3.
Maffei S, Franchini M, Fortunato L, Guiducci L. Long-term effects of a combination of isoflavones, agnus castus and magnolia extracts on climacteric symptoms and cardiometabolic risk profile in postmenopausal women. Gynecol Endocrinol. 2022 Apr;38(4):339-344. doi: 10.1080/09513590.2022.2047171. Epub 2022 Mar 8.
Silvia Maffei, MD
Fondazione Toscana Gabriele Monasterio
1,100 participants (actual enrollment reported by the registry).
First Submitted
September 7, 2018
First Posted
October 9, 2018
Study Start
June 22, 2012
Actual (reported)Contact the study team to confirm eligibility.
Guiducci L, Vassalle C, Parchi P, Maffei S. Monthly Intramuscular Neridronate for the Treatment of Postmenopausal Osteoporosis: Results of a 6-Year Prospective Italian Study. Int J Endocrinol. 2019 Feb 6;2019:9802827. doi: 10.1155/2019/9802827. eCollection 2019.
Primary Completion
December 31, 2017
Actual (reported)Study Completion
December 31, 2017
Actual (reported)Last Updated
October 9, 2018
Record last verified: 2018-10
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