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

Women's Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699150
• Other study ID #: 3605/2012
• Status: Completed
• Start date: June 22, 2012
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2018
• Source: Fondazione Toscana Gabriele Monasterio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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;

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Women's Health

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Silvia Maffei

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)