An observational study in Sickle Cell Disease and Sickle Cell Trait, sponsored by UConn Health. Recruiting at 1 site in United States. Open to female participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by UConn Health · Observational
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.
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.
43 studies on the registry are indexed under Sickle Cell Trait; 11 are open to participants now.
This study's planned enrollment of 50 is below the median of 109 across 20 observational studies indexed under Sickle Cell Trait.
Browse Sickle Cell Trait studies →UConn Health is the lead sponsor of 187 studies on the registry; 18 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Compared within Sickle Cell Trait, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anemia, Sickle Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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).
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).
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.
Time frame: Day 1
Difference in 25-OH vitamin D between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT)
Participants will undergo blood testing to measure 25-OH Vitamin D levels in nanograms per milliliter.
Time frame: Day 1
Difference in calcium between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT)
Participants will undergo blood testing to measure calcium levels in milligrams per deciliter.
Time frame: Day 1
Difference in parathyroid hormone between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT)
Participants will undergo blood testing to measure parathyroid hormone levels in picograms per milliliter.
Time frame: Day 1
Effect of sickle cell trait (SCT) on frailty in older African descent (AD) women
Participants will have frailty assessed using both the Fried phenotype and the Rockwood Frailty Index.
Time frame: Day 1
Effect of sickle cell trait (SCT) on muscle mass in older African descent (AD) women
Particpants will undergo dual energy xray absorptiometry to assess muscle mass.
Time frame: Day 1
Effect of sickle cell trait (SCT) on muscle function in older African descent (AD) women.
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.
Time frame: Day 1
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