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NCT Number: NCT07083531

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

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.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Observational

Primary location

UConn Health

Farmington, Connecticut, 06030, United States

Location status: Recruiting

Location contact

Biree Andemariam, M.D

PRINCIPAL_INVESTIGATOR

Sasia Jones, MPH

CONTACT

[email protected]

860.679.7879

About this study

This is a collaborative project involving three different disciplinary areas, including The Division of Hematology/Oncology, The Division of Endocrinology, and The Center on Aging (CoA)/Geriatrics in the UConn School of Medicine. The project consists of two specific aims: (1) determine effects of SCT on bone mineral density in postmenopausal women of African descent and (2) investigate the association of SCT on skeletal muscle function and frailty in postmenopausal women of African descent. The investigators hypothesize that individuals with SCT have reduced bone mineral density, decreased muscle function, and increased frailty compared to controls. This research may identify a hitherto unrecognized risk factor for racially disparate fracture incidence and outcomes in AD women. These findings will set the basis for a more extensive clinical study directly examining the association of SCT on fracture incidence and fracture-related morbidity and mortality.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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).

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)

    Time frame: Day 1

    Particpants will undergo dual energy xray absorptiometry.

Secondary outcomes

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

    Time frame: Day 1

    Participants will undergo blood testing to measure 25-OH Vitamin D levels in nanograms per milliliter.

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

    Time frame: Day 1

    Participants will undergo blood testing to measure calcium levels in milligrams per deciliter.

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

    Time frame: Day 1

    Participants will undergo blood testing to measure parathyroid hormone levels in picograms per milliliter.

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

    Time frame: Day 1

    Participants will have frailty assessed using both the Fried phenotype and the Rockwood Frailty Index.

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

    Time frame: Day 1

    Particpants will undergo dual energy xray absorptiometry to assess muscle mass.

  6. Effect of sickle cell trait (SCT) on muscle function in older African descent (AD) women.

    Time frame: Day 1

    Participants will undergo a 6-minute walk and gait velocity. In addition, the short physical performance battery (SPPB) will be measured. The SPPB is an objective assessment tool for evaluating lower extremity functioning in older persons, balance, lower extremity strength, and functional capacity.

Study contacts

Contact information is provided by the study sponsor or research team.

Zoe Green, BS

CONTACT

[email protected]

860.679.4656

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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