The Bone and hEArt Health Consequences of Ovarian agiNg (BEACON) Study

NCT07621965 | Not Yet Recruiting

• 1 other identifier: 31956
• Study Type: observational
• Target: 655
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ovarian aging is a major driver of a woman's long-term health and disease risk. In particular, the rapid decline in the ovarian reserve that occurs with the menopause transition is linked to a striking increase in the risk for both cardiometabolic disease and osteoporosis. A growing body of evidence has demonstrated that earlier age at menopause further exacerbates this risk for ischemic stroke, heart disease, and non-traumatic osteoporotic fracture. Thus, the identification of factors that accelerate ovarian aging is likely to lead to increased incidence and earlier onset of these conditions. Adverse pregnancy outcomes (APO) such as gestational diabetes, hypertensive disorders of pregnancy, and stillbirth, are major pathophysiological states that have the potential to accelerate depletion of the ovarian reserve due to the chronic inflammatory state, oxidative stress, and epigenetics changes that ensue. This proposal seeks to determine if APOs impact the ovarian aging trajectory and subsequent cardiometabolic and musculoskeletal health outcomes. Our central hypothesis is that APOs will accelerate ovarian aging, resulting in greater incidence and earlier onset of cardiometabolic disease and musculoskeletal decline. This hypothesis will be tested by accomplishing three aims designed to: 1) define the trajectory of ovarian aging and the impact of APOs on indicators of ovarian aging over time; 2) correlate the ovarian aging trajectory with the development of cardiometabolic risk; and 3) determine the association of ovarian aging biomarker trajectory on musculoskeletal health. To accomplish these aims we will capitalize on a subset of participants from the large, multisite nuMoM2b cohort that has been followed for fifteen years since the time of their first pregnancy. This project, the Bone and hEArt health Consequences of Ovarian agiNg (BEACON) Study, will utilize the extensive health, behavior, psychosocial and pregnancy data in this cohort, paired with biospecimens from their initial pregnancy and follow-up visits (3-7 \& 7-12 years after pregnancy), as well as data and specimens collected on participants completing an additional study visit. This proposal has the unique opportunity to provide longitudinal insight into the role of APOs in ovarian aging. If APOs are shown to accelerate ovarian aging, this mechanism may contribute to earlier onset of vascular dysfunction, metabolic disease, and musculoskeletal decline that would highlight the need for revised risk stratification for women with APOs, earlier screening (e.g., bone density, blood pressure \& lipids), and the development of targeted prevention strategies. Moreover, these findings could identify critical windows for intervention and reveal novel targets for earlier and more effective therapeutic strategies.

Conditions

Ovarian Aging; Adverse Pregnancy Outcomes

Keywords

ovarian aging; perimenopause; menopause; cardiovascular health; musculoskeletal health

Outcome Measures

Primary Outcomes (1)

• Ovarian aging

  AMH trajectory

  18 years

Eligibility Criteria

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

Study Population

Indiana University nuMoM2b-Heart Health Study participants.

You may qualify if:

• We will include all IU study participants (n=655) for these analyses to characterize the ovarian aging trajectory of the cohort over time. The approach will allow us to move forward with the ovarian aging biomarker assays while recruitment for the in-person visit is ongoing. We will recruit a subgroup of current the IU cohort (n=352) to complete an in-person study visit at the FIT Core and Clinical Research Center. We will only recruit those who are at least 35 years old to this subgroup.

You may not qualify if:

• We will exclude any potential participants who are unable to provide written informed consent in English or Spanish (the only languages allowed at the IU site for nuMoM2b), if the participant is currently pregnant, has undergone recent major surgery or sustained major injury or broken bones within 6 months of recruitment.

Sponsors & Collaborators

• Indiana University: lead

Central Study Contacts

David Haas, MD

CONTACT

13172742027; dahaas@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): March 30, 2032
• Study Completion (Estimated): March 30, 2032
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL