NCT03699150

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

Completed Last updated 9 October 2018

What this trial tests

trial in Women's Health in 1,100 participants. Completed in 31 December 2017.

Timeline

22 June 2012

Primary endpoint
31 December 2017

31 December 2017

Quick facts

Lead sponsor	Silvia Maffei
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,100
Start date	22 June 2012
Primary completion	31 December 2017
Estimated completion	31 December 2017

Conditions studied

• Women's Health — all drugs for Women's Health →

Sponsor

Silvia Maffei

Who can join

Eligibility, female only, with Women's Health. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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;

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Ospemifene on Densitometric and Plasma Bone Metabolism Biomarkers in Postmenopausal Women Reporting Vulvar and Vaginal Atrophy (VVA).
   Maffei S, Guiducci L. · · 2022 · cited 5× · PMID 36362542 · DOI 10.3390/jcm11216316
2. Nutritional interventions in treating menopause-related sleep disturbances: a systematic review.
   Polasek D, Santhi N, Alfonso-Miller P, Walshe IH, et al · · 2024 · cited 4× · PMID 37695299 · DOI 10.1093/nutrit/nuad113
3. Monthly Intramuscular Neridronate for the Treatment of Postmenopausal Osteoporosis: Results of a 6-Year Prospective Italian Study.
   Guiducci L, Vassalle C, Parchi P, Maffei S. · · 2019 · cited 3× · PMID 30881452 · DOI 10.1155/2019/9802827
4. Long-term effects of a combination of isoflavones, agnus castus and magnolia extracts on climacteric symptoms and cardiometabolic risk profile in postmenopausal women.
   Maffei S, Franchini M, Fortunato L, Guiducci L. · · 2022 · cited 2× · PMID 35257639 · DOI 10.1080/09513590.2022.2047171
5. Body composition and cardiometabolic risk reduction following therapy with a multi-ingredient nutraceutical formulation: a real-life clinical study.
   Sironi AM, Franchini M, Tessieri V, Maffei S. · · 2026 · PMID 42205923 · DOI 10.7573/dic.2025-12-7