Cardio-metabolic Risk Factors, Osteoporosis and Thrombus Embolic Assessment, Along Woman's Life

Cardio-metabolic Risk Factors, Osteoporosis and Thrombus Embolic Assessment, Along Woman's Life: an Observational Retrospective Study

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;

Study Overview

• Status: Completed
• Conditions: Women's Health

Detailed Description

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 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. Moreover some pathological but reversible conditions during pregnancy may represent an incursion in metabolic syndrome and a sing of future cardiovascular disease.

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; in outpatients referring to FTGM Ambulatory of cardiovascular gynecology and osteoporosis in Pisa.

• Study Type: Observational
• Enrollment (Actual): 1100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Outpatients referred to the Gynecologic Endocrinology and Osteoporosis Unit of Fondazione CNR-Regione Toscana G. Monasterio, Pisa, Italy.

Description

Inclusion Criteria:

• Outpatients referred to the Gynecologic Endocrinology and Osteoporosis Unit of Fondazione CNR-Regione Toscana G. Monasterio, Pisa, Italy, who have authorized the use of their personal data

Exclusion Criteria:

• History of/or current neoplastic disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Postmenopausal women; Outpatients referred to the Gynecologic Endocrinology, FTGM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of HRT and metabolic treatments on change of insulin sensitivity, lipidemic and inflammatory profile, coagulation, anthropometric parameters in menopausal transition and postmenopausal women.	improvement of climacteric symptoms (Green Scale)	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	For each patient were collected: Bone DEXA: lumbar spine, total femoral (TF) and femoral neck (FN): BMD (g/cm2 ) of L1-L4, FN and TF BMD (g/cm2)	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	For each patient were collected: Bone DEXA: lumbar spine, total femoral (TF) and femoral neck (FN): T-Score L1-L4, T-Score FN, T-Score TF	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	For each patient were collected: Blood-markers of bone metabolism: Total Calcium(mmol/L), Ionized Calcium(mmol/L), alkaline bone phosphatase(ng/mL), Osteocalcin(ng/mL), Procollagen typeI, CTx(ng/mL), NTx(ng/mL), PTH(pg/mL), Vit D 25-OH(ng/mL).	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)

Collaborators and Investigators

• Sponsor: Silvia Maffei
• Investigators: Principal Investigator: Silvia Maffei, MD, Fondazione Toscana Gabriele Monasterio

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2012
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: 3605/2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No