Sickle Cell Hemoglobinopathies and Bone Health

March 24, 2025 updated by: Biree Andemariam, UConn Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • UConn Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The target population includes healthy African American female volunteers with and without SCT and African American female volunteers with SCD.

Description

Inclusion Criteria:

  • Age 18-45 years.
  • Female.
  • Regular menstrual periods.
  • Self-identification of African American race.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Healthy volunteers without SCT
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 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.
Other: Healthy volunteers with SCT
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 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.
Other: Volunteers with SCD
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UConn Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Biree Andemariam, MD, UConn Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-136-6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sickle Cell Disease

Clinical Trials on Healthy volunteers without SCT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings