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

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
UConn Health
Study ID
NCT07083531
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Aug 23, 2022
Status verified
Mar 2025
Primary completion
Aug 23, 2025
Completion
Aug 23, 2025

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Healthy volunteers without SCT
    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.
  • Arm: Healthy volunteers with 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UConn HealthFarmingtonConnecticut06030
Sasia Jones, MPH
[email protected]
860.679.7879
Biree Andemariam, M.D (PRINCIPAL_INVESTIGATOR)

Find similar trials in Farmington, CT

By condition
Sickle cell disease
By research site
UConn Health· Farmington, CT

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