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

NCT03699150 | Completed

• 1 other identifier: 3605/2012
• Study Type: observational
• Target: 1,100
• Locations: 0 countries
• Sites: N/A

Brief 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;

Conditions

Women's Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

Study Arms (1)

Postmenopausal women

Outpatients referred to the Gynecologic Endocrinology, FTGM

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• History of/or current neoplastic disease

Sponsors & Collaborators

• Silvia Maffei: lead

Related Publications (2)

• 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.

  PMID: 35257639 DERIVED

• 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.

  PMID: 30881452 DERIVED

Study Officials

• Silvia Maffei, MD

  Fondazione Toscana Gabriele Monasterio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: October 9, 2018
• Study Start: June 22, 2012
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share