Recruiting

SCT vs. NormalBone Loss, Physical Function and Frailty in Older Women With Sickle Cell Trait Sickle Cell Trait

Sponsor:

UConn Health

Code:

NCT07083531

Conditions

Sickle Cell Disease

Sickle Cell Trait

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Accepted

Interventions

Healthy volunteers without SCT

Healthy volunteers with SCT

Study Details

Brief summary:

This is a cross-sectional, clinical research study comparing postmenopausal women of African Descent (AD) with different hemoglobin genotypes: normal and sickle cell trait (SCT). This research study has two purposes. The first purpose is to determine whether having SCT is a risk factor for the development of bone thinning in older women. The second purpose is to investigate whether women with SCT have reduced muscle function and increased frailty compared to women without SCT. The investigators estimate enrolling 50 female volunteers who are at least 50 years old and have not had a menstrual period for at least 12 consecutive months. Volunteers need not know whether they have SCT as this will be evaluated as part of the study.

Conditions

Sickle Cell Disease

Sickle Cell Trait

Study ID

NCT07083531

Start date

Aug 23, 2022

Status verified date

Mar, 2025

Completion date

Aug 23, 2025

Anticipated

Primary completion date

Aug 23, 2025

Anticipated

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Accepted

Inclusion Criteria:

Female of African Decent.
Age 50 years or older.
Lack of menstrual period for at least 12 consecutive months

Exclusion Criteria:

Taking medications known to influence bone metabolism (e.g., glucocorticoids, hormonal therapy, cancer or chemotherapy meds, anti-resorptive medications or anabolic therapies).
Known metabolic bone disorder (e.g., uncontrolled thyroid disease, hyperparathyroidism, Vitamin D deficiency)
Taking an investigational drug
Documented sickle cell disease

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy volunteers without SCT

Healthy women of African descent at least 50 years old without sickle cell trait and who have not had a menstrual period for at least 12 consecutive months.

Healthy volunteers with SCT

Healthy women of African descent at least 50 years old with sickle cell trait and who have not had a menstrual period for at least 12 consecutive months.

Interventions

Healthy volunteers without SCT

Participants will donate blood for serum bone turnover markers, complete blood count, calcium, phosphorus, albumin, parathyroid hormone, and hemoglobin electrophoresis. Participants will undergo a bone density evaluation and muscle mass measurement via dual-energy x-ray absorptiometry (DEXA) scanning. Participants will fill out dietary calcium intake and pain burden questionnaires. Participants will fill out a survey for frailty assessment, undergo 6-minute walk gait velocity and short physical performance battery (SPPB).

Healthy volunteers with SCT

Primary outcome measure

Difference in bone mineral density between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Zoe Green, BS

860.679.4656 zgreen@uchc.edu

Locations

UConn Health

Recruiting

Farmington, Connecticut, United States, 06030

Contacts

Sasia Jones, MPH

860.679.7879 Sajones@uchc.edu

Principal Investigator:

Biree Andemariam, M.D

More Information

Sponsor

UConn Health

Last update posted

Jul 24, 2025

Last verified

Mar, 2025

Keywords

Sickle Cell Disease (SCD)
Sickle Cell Trait (SCT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UConn Health on 2025-07-24.