RecruitingNCT07083531

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

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


Sponsor

UConn Health

Enrollment

50 participants

Start Date

Aug 23, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 50 Years

Inclusion Criteria3

  • Female of African Decent.
  • Age 50 years or older.
  • Lack of menstrual period for at least 12 consecutive months

Exclusion Criteria4

  • 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

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Interventions

OTHERHealthy 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 performance battery (SPPB).

OTHERHealthy 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).


Locations(1)

UConn Health

Farmington, Connecticut, United States

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NCT07083531


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