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Trial record 1 of 1 for:    NCT03699150
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Cardio-metabolic Risk Factors, Osteoporosis and Thrombus Embolic Assessment, Along Woman's Life

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ClinicalTrials.gov Identifier: NCT03699150
Recruitment Status : Completed
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Silvia Maffei, Fondazione Toscana Gabriele Monasterio

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;


Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cardio-metabolic Risk Factors, Osteoporosis and Thrombus Embolic Assessment, Along Woman's Life: an Observational Retrospective Study
Actual Study Start Date : June 22, 2012
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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



Primary Outcome Measures :
  1. Effects of different contraceptive therapies on change of insulin sensitivity, lipidemic and inflammatory profile, coagulation and anthropometric parameters in fertile age women [ Time Frame: 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) ]

    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)



Secondary Outcome Measures :
  1. Effects of HRT and metabolic treatments on change of insulin sensitivity, lipidemic and inflammatory profile, coagulation, anthropometric parameters in menopausal transition and postmenopausal women. [ Time Frame: 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) ]
    improvement of climacteric symptoms (Green Scale)

  2. Effects of "bone therapies" on change of bone mineral density (BMD) in menopausal transition and post-menopausal women [ Time Frame: 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) ]

    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)


  3. Effects of "bone therapies" on change of T-score in menopausal transition and post-menopausal women [ Time Frame: 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) ]

    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


  4. Effects of "bone therapies" on change of Blood-markers of bone metabolism in menopausal transition and post-menopausal women [ Time Frame: 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) ]

    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).




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatients referred to the Gynecologic Endocrinology and Osteoporosis Unit of Fondazione CNR-Regione Toscana G. Monasterio, Pisa, Italy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699150


Sponsors and Collaborators
Silvia Maffei
Investigators
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Principal Investigator: Silvia Maffei, MD Fondazione Toscana Gabriele Monasterio
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Silvia Maffei, Principal Investigator, Fondazione Toscana Gabriele Monasterio
ClinicalTrials.gov Identifier: NCT03699150    
Other Study ID Numbers: 3605/2012
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases