Sickle Cell DiseaseNCT07083531
Bone Loss, Physical Function and Frailty in Older Women With Sickle Cell Trait Sickle Cell Trait
An observational study of Sickle Cell Disease and Sickle Cell Trait, run by UConn Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease, Sickle Cell Trait
- What is being tested?
- Healthy volunteers without SCT and Healthy volunteers with SCT
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to 23 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- Female of African Decent.
- Age 50 years or older.
- Lack of menstrual period for at least 12 consecutive months
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UConn Health
Farmington, Connecticut, 06030
Sasia Jones, MPH, 860.679.7879, Sajones@uchc.edu
Biree Andemariam, M.D
About this study
Official title: Bone Loss, Physical Function and Frailty in Older Women With Sickle Cell Trait
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.
Read the 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.
- Conditions
- Sickle Cell Disease, Sickle Cell Trait
- Being tested
- Healthy volunteers without SCT, Healthy volunteers with SCT
- Keywords
- Sickle Cell Disease (SCD), Sickle Cell Trait (SCT)
- Medical subject headings
- Anemia, Sickle Cell, Sickle Cell Trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy volunteers without SCTOther
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 SCTOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Healthy volunteers without SCT | |
| 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. Receives: Other: Healthy volunteers with SCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (6)
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Effect of sickle cell trait (SCT) on muscle mass in older African descent (AD) women
Particpants will undergo dual energy xray absorptiometry to assess muscle mass.
Measured: Day 1
Effect of sickle cell trait (SCT) on muscle function in older African descent (AD) women.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start23 Aug 2022
- Primary completion23 Aug 2025 (estimated)
- Study completion23 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biree Andemariam, UConn Health
- Investigators
- Biree Andemariam, MD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083531
- Sponsor's protocol ID
- 22-327-1
- Status last verified
- Mar 2025
- First submitted
- 24 Jun 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Loss, Physical Function and Frailty in Older Women With Sickle Cell Trait
- ClinicalTrials.gov ID
- NCT07083531
- Acronym / sponsor ID
- 22-327-1
- Conditions
- Sickle Cell Disease, Sickle Cell Trait
- Keywords
- Sickle Cell Disease (SCD), Sickle Cell Trait (SCT)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 23 Aug 2025 (estimated)
- Study completion
- 23 Aug 2025 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers without SCT | – | Other: Healthy volunteers without SCTHealthy 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. |
| Healthy volunteers with SCT | – | Other: Healthy volunteers with SCTHealthy 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- Female of African Decent.
- Age 50 years or older.
- Lack of menstrual period for at least 12 consecutive months
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy volunteers without SCTParticipants 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). | Other | Healthy volunteers without SCT |
| Healthy volunteers with SCTParticipants 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). | Other | Healthy volunteers with SCT |
Primary outcome
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
Particpants will undergo dual energy xray absorptiometry.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Biree Andemariam, MD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Sickle Cell Trait, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe Green, BS (860.679.4656, zgreen@uchc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.