Bone Loss, Physical Function and Frailty in Older Women With Sickle Cell Trait Sickle Cell Trait
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age50+
SponsorUConn Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female of African Decent.
Age 50 years or older.
Lack of menstrual period for at least 12 consecutive months
Disqualifiers
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
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Healthy volunteers without SCT
Other interventionParticipants 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 interventionParticipants 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).
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Healthy volunteers without SCT1 intervention
Group B: Healthy volunteers with SCT1 intervention
Trial outcomes
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.
Time frame
Day 1Secondary 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)
Participants will undergo blood testing to measure 25-OH Vitamin D levels in nanograms per milliliter.
Time frame
Day 12
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 13
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 14
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 1Sponsors and contacts
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Source ClinicalTrials.gov