Sickle Cell DiseaseNCT02306993
Sickle Cell Hemoglobinopathies and Bone Health
An observational study of Sickle Cell Disease and Sickle Cell Trait, run by UConn Health at 1 site in United States.
Trial summary
This research study has two purposes. The first purpose is to determine whether having sickle cell trait (SCT) is a risk factor for the development of bone thinning at an earlier age than expected. Nearly 10% of African Americans (AA) carry sickle cell trait and most of them are unaware of it. Read more about this study
- Who is it for?
- Ages 18 to 45 years, 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, Healthy volunteers with SCT and Volunteers with SCD
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Nov 2028
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The target population includes healthy African American female volunteers with and without SCT and African American female volunteers with SCD.
Who may be able to join
- Age 18-45 years.
- Female.
- Regular menstrual periods.
- Self-identification of African American race.
Who cannot join
- Taking oral contraceptives or medications known to influence bone metabolism (e.g. Glucocorticoids, anti-resorptive or anabolic medications for osteoporosis, pharmacologic Vit D dosing).
- Known metabolic bone disorder (e.g. uncontrolled thyroid disease, hyperparathyroidism).
- Pregnant, breast-feeding, or within 3 months post-partum.
- Taking an investigational drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sickle Cell Hemoglobinopathies and Bone Heath
This research study has two purposes. The first purpose is to determine whether having sickle cell trait (SCT) is a risk factor for the development of bone thinning at an earlier age than expected. Nearly 10% of African Americans (AA) carry sickle cell trait and most of them are unaware of it. African Americans are less likely to develop thin bones than whites, but if they sustain a bone fracture, they are more likely to die from it. We believe having sickle cell trait may lead to bone thinning and predispose a subset of African Americans to dangerously thin bones. The second purpose is to try to understand why individuals with sickle cell disease (SCD) have thinner bones than healthy individuals do. Doctors have already discovered that people with sickle cell disease have very thin bones, but they have not determined why. Our study will try to identify whether the bone thinning is from the body not making enough bone or from the body losing bone once it is made.
Read the detailed description
SCD is a hereditary disease arising only when two parents carrying sickle cell trait (SCT) conceive a child. SCT is clinically silent but very common in African Americans with a ~10% prevalence, although most carriers are unaware of their status. There are no data on bone mineral density (BMD) or vitamin D status in these individuals. Although it is clear that those with SCD have accelerated bone thinning the effect of SCT on bone metabolism or fractures has not been studied. Although the incidence of hip fracture in AA women is about half that of white women, the etiology and risk factors of fractures in AA women are not clearly defined, and it is intriguing to postulate that SCT may have a relationship to bone metabolism and fracture risk in this population, and thus contribute to racial disparity. We hypothesize that the mechanisms underlying altered bone homeostasis in SCD are different than in the general population but perhaps similar to those with SCT. We also hypothesize that SCT is a state of reduced bone mineralization which may contribute to racially disparate outcomes among AAs with bone fractures. Our objectives are (1) to define the mechanisms of bone loss in SCD and (2) to evaluate parameters of bone metabolism in human subjects with SCT compared to those with normal hemoglobin and those with SCD. We will investigate the effect of SCD and SCT on bone homeostasis in premenopausal AA subjects via serum bone turnover markers, calciotrophic hormones and bone mineral density (BMD) testing. We hypothesize that premenopausal AA women with SCT will have significantly lower BMD and higher serum bone turnover markers than race- and age-matched control AA women. In addition, we will explore Vitamin D status and its relationship to bone turnover and BMD in all three groups. We further postulate that bone homeostasis in SCT subjects will be intermediate between healthy controls and subjects with SCD.
- Conditions
- Sickle Cell Disease, Sickle Cell Trait
- Being tested
- Healthy volunteers without SCT, Healthy volunteers with SCT, Volunteers with SCD
- 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
Subjects will undergo bone density evaluation via dual energy x-ray absorptiometry (DEXA) scanning. Subjects will provide a sample of for testing of bone turnover markers, complete blood count, and hemoglobin electrophoresis. Subjects will provide information about their dietary calcium intake and pain burden.
Healthy volunteers with SCTOther
Subjects will undergo bone density evaluation via dual energy x-ray absorptiometry (DEXA) scanning. Subjects will provide a sample of for testing of bone turnover markers, complete blood count, and hemoglobin electrophoresis. Subjects will provide information about their dietary calcium intake and pain burden.
Volunteers with SCDOther
Subjects will undergo bone density evaluation via dual energy x-ray absorptiometry (DEXA) scanning. Subjects will provide a sample of for testing of bone turnover markers, complete blood count, and hemoglobin electrophoresis. Subjects will provide information about their dietary calcium intake and pain burden.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers without SCT | Includes Healthy African American female volunteer between the ages of 18 and 45 years without sickle cell trait. Their blood and bone density x-ray will help researchers gain a better understanding of what might be different about the way having sickle cell trait affects bone. Receives: Other: Healthy volunteers without SCT | |
| Healthy volunteers with SCT | Includes Healthy African American female volunteer between the ages of 18 and 45 years with sickle cell trait. Their blood and bone density x-ray will help researchers gain a better understanding of what might be different about the way having sickle cell trait affects bone. Receives: Other: Healthy volunteers with SCT | |
| Volunteers with SCD | Healthy African American female volunteer between the ages of 18 and 45 years with sickle cell disease. Their blood and bone density x-ray will help researchers gain a better understanding of what might be different about the way having sickle cell disease affects bone. Receives: Other: Volunteers with SCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin genotype with serum bone turnover markers and bone density
Assess the association of hemoglobin genotype with serum bone turnover markers and bone density.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 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
- NCT02306993
- Sponsor's protocol ID
- 14-136-6
- Status last verified
- Aug 2026
- First submitted
- 1 Dec 2014
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sickle Cell Hemoglobinopathies and Bone Heath
- ClinicalTrials.gov ID
- NCT02306993
- Acronym / sponsor ID
- 14-136-6
- Conditions
- Sickle Cell Disease, Sickle Cell Trait
- Keywords
- Sickle Cell Disease (SCD), Sickle Cell Trait (SCT)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- 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 research study has two purposes. The first purpose is to determine whether having sickle cell trait (SCT) is a risk factor for the development of bone thinning at an earlier age than expected. Nearly 10% of African Americans (AA) carry sickle cell trait and most of them are unaware of it. African Americans are less likely to develop thin bones than whites, but if they sustain a bone fracture, they are more likely to die from it. We believe having sickle cell trait may lead to bone thinning and predispose a subset of African Americans to dangerously thin bones. The second purpose is to try to understand why individuals with sickle cell disease (SCD) have thinner bones than healthy individuals do. Doctors have already discovered that people with sickle cell disease have very thin bones, but they have not determined why. Our study will try to identify whether the bone thinning is from the body not making enough bone or from the body losing bone once it is made.
Detailed description
SCD is a hereditary disease arising only when two parents carrying sickle cell trait (SCT) conceive a child. SCT is clinically silent but very common in African Americans with a ~10% prevalence, although most carriers are unaware of their status. There are no data on bone mineral density (BMD) or vitamin D status in these individuals. Although it is clear that those with SCD have accelerated bone thinning the effect of SCT on bone metabolism or fractures has not been studied. Although the incidence of hip fracture in AA women is about half that of white women, the etiology and risk factors of fractures in AA women are not clearly defined, and it is intriguing to postulate that SCT may have a relationship to bone metabolism and fracture risk in this population, and thus contribute to racial disparity. We hypothesize that the mechanisms underlying altered bone homeostasis in SCD are different than in the general population but perhaps similar to those with SCT. We also hypothesize that SCT is a state of reduced bone mineralization which may contribute to racially disparate outcomes among AAs with bone fractures. Our objectives are (1) to define the mechanisms of bone loss in SCD and (2) to evaluate parameters of bone metabolism in human subjects with SCT compared to those with normal hemoglobin and those with SCD. We will investigate the effect of SCD and SCT on bone homeostasis in premenopausal AA subjects via serum bone turnover markers, calciotrophic hormones and bone mineral density (BMD) testing. We hypothesize that premenopausal AA women with SCT will have significantly lower BMD and higher serum bone turnover markers than race- and age-matched control AA women. In addition, we will explore Vitamin D status and its relationship to bone turnover and BMD in all three groups. We further postulate that bone homeostasis in SCT subjects will be intermediate between healthy controls and subjects with SCD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers without SCT | – | Other: Healthy volunteers without SCTIncludes Healthy African American female volunteer between the ages of 18 and 45 years without sickle cell trait. Their blood and bone density x-ray will help researchers gain a better understanding of what might be different about the way having sickle cell trait affects bone. |
| Healthy volunteers with SCT | – | Other: Healthy volunteers with SCTIncludes Healthy African American female volunteer between the ages of 18 and 45 years with sickle cell trait. Their blood and bone density x-ray will help researchers gain a better understanding of what might be different about the way having sickle cell trait affects bone. |
| Volunteers with SCD | – | Other: Volunteers with SCDHealthy African American female volunteer between the ages of 18 and 45 years with sickle cell disease. Their blood and bone density x-ray will help researchers gain a better understanding of what might be different about the way having sickle cell disease affects bone. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The target population includes healthy African American female volunteers with and without SCT and African American female volunteers with SCD.
Key inclusion criteria (4 listed)
- Age 18-45 years.
- Female.
- Regular menstrual periods.
- Self-identification of African American race.
Key exclusion criteria (4 listed)
- Taking oral contraceptives or medications known to influence bone metabolism (e.g. Glucocorticoids, anti-resorptive or anabolic medications for osteoporosis, pharmacologic Vit D dosing).
- Known metabolic bone disorder (e.g. uncontrolled thyroid disease, hyperparathyroidism).
- Pregnant, breast-feeding, or within 3 months post-partum.
- Taking an investigational drug.
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 SCTSubjects will undergo bone density evaluation via dual energy x-ray absorptiometry (DEXA) scanning. Subjects will provide a sample of for testing of bone turnover markers, complete blood count, and hemoglobin electrophoresis. Subjects will provide information about their dietary calcium intake and pain burden. | Other | Healthy volunteers without SCT |
| Healthy volunteers with SCTSubjects will undergo bone density evaluation via dual energy x-ray absorptiometry (DEXA) scanning. Subjects will provide a sample of for testing of bone turnover markers, complete blood count, and hemoglobin electrophoresis. Subjects will provide information about their dietary calcium intake and pain burden. | Other | Healthy volunteers with SCT |
| Volunteers with SCDSubjects will undergo bone density evaluation via dual energy x-ray absorptiometry (DEXA) scanning. Subjects will provide a sample of for testing of bone turnover markers, complete blood count, and hemoglobin electrophoresis. Subjects will provide information about their dietary calcium intake and pain burden. | Other | Volunteers with SCD |
Primary outcome
Hemoglobin genotype with serum bone turnover markers and bone density
Time frame: 3 years
Assess the association of hemoglobin genotype with serum bone turnover markers and bone density.
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 Aug 2026.
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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. This study is not recruiting at the moment.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin genotype with serum bone turnover markers and bone density (time frame: 3 years). 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 Aug 2026.