Bone Loss, Physical Function and Frailty in Older Women With Sickle Cell Trait Sickle Cell Trait

NCT07083531 | Recruiting DMC

• 1 other identifier: 22-327-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Difference in bone mineral density between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT)

  Particpants will undergo dual energy xray absorptiometry.

  Day 1

Secondary Outcomes (6)

• Difference in 25-OH vitamin D between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT)

  Day 1

• Difference in calcium between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT)

  Day 1

• Difference in parathyroid hormone between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT)

  Day 1

• Effect of sickle cell trait (SCT) on frailty in older African descent (AD) women

  Day 1

• Effect of sickle cell trait (SCT) on muscle mass in older African descent (AD) women

  Day 1

Study Arms (2)

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.

Other: Healthy volunteers without SCT

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.

Other: Healthy volunteers with SCT

Interventions

Healthy volunteers without SCT OTHER

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 without SCT

Healthy volunteers with SCT OTHER

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

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Postmenopausal female volunteers of African Descent
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population includes healthy age-matched postmenopausal female volunteers of African Descent with and without SCT. Subjects will be eligible if they are at least 50 years old and have not had a menstrual period for at least 12 consecutive months.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Once informed consent and HIPAA authorization are obtained, a certified member of the research staff will perform the venipuncture for CBC, hemoglobin electrophoresis, blood serum bone turnover markers, phosphate, calcium, and vitamin D analysis. Research participants will donate approximately 12-15 cc of whole blood via venipuncture.

MeSH Terms

Conditions

Anemia, Sickle Cell; Sickle Cell Trait

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Biree Andemariam, MD

  UConn Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe Green, BS

CONTACT

860.679.4656; zgreen@uchc.edu

Study Design

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

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 24, 2025
• Study Start: August 23, 2022
• Primary Completion: August 23, 2025
• Study Completion: August 23, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-03

Locations

US (1)