UConn Health
Farmington, Connecticut, 06030, United States
Location status: Recruiting
Location contact
Biree Andemariam, M.D
PRINCIPAL_INVESTIGATOR
Sasia Jones, MPH
CONTACT
NCT Number: NCT07083531
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.
Interested in participating?
Request Info50 year and older
Female
Observational
Farmington, Connecticut, 06030, United States
Location status: Recruiting
Biree Andemariam, M.D
PRINCIPAL_INVESTIGATOR
Sasia Jones, MPH
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Day 1
Particpants will undergo dual energy xray absorptiometry.
Time frame: Day 1
Participants will undergo blood testing to measure 25-OH Vitamin D levels in nanograms per milliliter.
Time frame: Day 1
Participants will undergo blood testing to measure calcium levels in milligrams per deciliter.
Time frame: Day 1
Participants will undergo blood testing to measure parathyroid hormone levels in picograms per milliliter.
Time frame: Day 1
Participants will have frailty assessed using both the Fried phenotype and the Rockwood Frailty Index.
Time frame: Day 1
Particpants will undergo dual energy xray absorptiometry to assess muscle mass.
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.
Contact information is provided by the study sponsor or research team.
UConn Health
Other
Bone Loss, Physical Function and Frailty in Older Women With Sickle Cell Trait
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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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