Bone Loss, Physical Function and Frailty in Older Women With Sickle Cell Trait Sickle Cell Trait
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Healthy volunteers without SCT, Healthy volunteers with SCT.
- Who it may be relevant to
- Registry conditions: Sickle Cell Disease, Sickle Cell Trait. Basic parameters: from 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Bone Loss, Physical Function and Frailty in Older Women With Sickle Cell Trait
Overview
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.
Detailed description
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.
Interventions
- Other 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 - 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
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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]
- Difference in calcium between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) [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) [Time frame: Day 1]
- Effect of sickle cell trait (SCT) on frailty in older African descent (AD) women [Time frame: Day 1]
- Effect of sickle cell trait (SCT) on muscle mass in older African descent (AD) women [Time frame: Day 1]
- Effect of sickle cell trait (SCT) on muscle function in older African descent (AD) women. [Time frame: Day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- UConn Health — Farmington
Identifiers
NCT: NCT07083531 · 22-327-1