OsteoporosisNCT01939470
Oklahoma Native American Women's Osteoporosis Screening Study
An observational study of Osteoporosis, run by Oklahoma State University at 1 site in United States.
Trial summary
Native American women may be considered high risk for osteoporosis due to lifestyle factors and incidence of type 2 diabetes. The objectives of this study are to: 1) determine the prevalence of osteopenia/osteoporosis in Native American female volunteers; 2) to evaluate their rate of bone loss; 3) to assess the… 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
- Osteoporosis
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Community sample of Native American who are eligible for health care services at Indian Health Clinics in the Oklahoma City area
Who may be able to join
- Native American women who are eligible fore services at Indian Health Clinics in OKC
- 50 years of age or older
Who cannot join
- Women who weigh more than 300 lbs or who are pregnant or cognitively impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
About this study
Native American women may be considered high risk for osteoporosis due to lifestyle factors and incidence of type 2 diabetes. The objectives of this study are to: 1) determine the prevalence of osteopenia/osteoporosis in Native American female volunteers; 2) to evaluate their rate of bone loss; 3) to assess the relationship between lifestyle factors, inflammatory mediators, and select endocrine parameters on osteoporosis risk; and 4) determine the barriers to treatment. Participants will undergo a baseline, Year 1 and Year 2 follow-up osteoporosis risk assessment. Data will be analyzed using repeated measures ANOVA and logistical regression.
Read the detailed description
Osteoporosis, characterized by decreased bone density and deterioration in bone microarchitecture, is estimated to afflict 1 out of 2 women over the age of 50 years. These estimates are based primarily on Caucasian populations with limited information in Native Americans. Native American women may be considered high risk for osteoporosis due to lifestyle factors in conjunction with the incidence of diabetes. The objectives of this study are to: 1) determine the prevalence of osteopenia/osteoporosis in Native American female volunteers, aged 50+ years, who are eligible for health care through Indian Health Services; 2) to evaluate their rate of bone loss, 3) to assess the relationship between lifestyle factors, inflammatory mediators, and select endocrine parameters on osteoporosis risk; and 4) determine the barriers to treatment. Native American women aged, 50+ years, who are eligible for services through Indian Health Services in the Oklahoma City (OKC) Area will be recruited. Participants will undergo a baseline osteoporosis risk assessment, i.e. medical history, dual-energy x-ray absorptiometry (DXA) scans, dietary and physical activity assessment, and optional blood draw, and then encouraged to return to their primary care physician for counsel and/or treatment. Serum markers of bone metabolism, endocrine parameters (e.g. vitamin D metabolites) and inflammatory molecules will be assessed for participants that consent to the blood draw. All participants will receive educational information related to osteoporosis risk and prevention, and follow-up visits scheduled at the end of Year 1 and Year 2. Data will be analyzed using repeated measures ANOVA and logistical regression with the α set at 0.05 for statistical significance.
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, bone, inflammation, diabetes, vitamin D
- Medical subject headings
- Osteoporosis, Inflammation, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Native American Women | Native American Women over the age of 50 yrs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Bone Mineral Density at Year 1 and Year 2
Measured: Baseline, year 1 and year 2
Secondary outcomes (5)
Change from Baseline in Serum Bone Formation Markers (bone-specific alkaline phosphatase) at Year 1 and Year 2
Measured: Baseline, year 1 and year 2
Change from Baseline in Bone Resorption Markers (C-telopeptide) at Year 1 and Year 2
Measured: Baseline, year 1 and year 2
Change from Baseline in Serum 25-Hydroxy Vitamin D at Year 1 and Year 2
Measured: Baseline, year 1 and year 2
Change from Baseline in Serum Interleukin-6 at Year 1 and Year 2
Measured: Baseline, year 1 and year 2
Change from Baseline in C-reactive Protein at Year 1 and Year 2
Measured: Baseline, year 1 and year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startOct 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenda J. Smith, Ph.D., Principal investigator, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939470
- Sponsor's protocol ID
- HE0840
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2013
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oklahoma Native American Women's Osteoporosis Screening Study
- ClinicalTrials.gov ID
- NCT01939470
- Acronym / sponsor ID
- HE0840
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, bone, inflammation, diabetes, vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Study start
- Oct 2007 (actual)
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Sep 2013 (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.
Native American women may be considered high risk for osteoporosis due to lifestyle factors and incidence of type 2 diabetes. The objectives of this study are to: 1) determine the prevalence of osteopenia/osteoporosis in Native American female volunteers; 2) to evaluate their rate of bone loss; 3) to assess the relationship between lifestyle factors, inflammatory mediators, and select endocrine parameters on osteoporosis risk; and 4) determine the barriers to treatment. Participants will undergo a baseline, Year 1 and Year 2 follow-up osteoporosis risk assessment. Data will be analyzed using repeated measures ANOVA and logistical regression.
Detailed description
Osteoporosis, characterized by decreased bone density and deterioration in bone microarchitecture, is estimated to afflict 1 out of 2 women over the age of 50 years. These estimates are based primarily on Caucasian populations with limited information in Native Americans. Native American women may be considered high risk for osteoporosis due to lifestyle factors in conjunction with the incidence of diabetes. The objectives of this study are to: 1) determine the prevalence of osteopenia/osteoporosis in Native American female volunteers, aged 50+ years, who are eligible for health care through Indian Health Services; 2) to evaluate their rate of bone loss, 3) to assess the relationship between lifestyle factors, inflammatory mediators, and select endocrine parameters on osteoporosis risk; and 4) determine the barriers to treatment. Native American women aged, 50+ years, who are eligible for services through Indian Health Services in the Oklahoma City (OKC) Area will be recruited. Participants will undergo a baseline osteoporosis risk assessment, i.e. medical history, dual-energy x-ray absorptiometry (DXA) scans, dietary and physical activity assessment, and optional blood draw, and then encouraged to return to their primary care physician for counsel and/or treatment. Serum markers of bone metabolism, endocrine parameters (e.g. vitamin D metabolites) and inflammatory molecules will be assessed for participants that consent to the blood draw. All participants will receive educational information related to osteoporosis risk and prevention, and follow-up visits scheduled at the end of Year 1 and Year 2. Data will be analyzed using repeated measures ANOVA and logistical regression with the α set at 0.05 for statistical significance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Native American Women | – | –Native American Women over the age of 50 yrs |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample of Native American who are eligible for health care services at Indian Health Clinics in the Oklahoma City area
Key inclusion criteria (2 listed)
- Native American women who are eligible fore services at Indian Health Clinics in OKC
- 50 years of age or older
Key exclusion criteria (1 listed)
- Women who weigh more than 300 lbs or who are pregnant or cognitively impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in Bone Mineral Density at Year 1 and Year 2
Time frame: Baseline, year 1 and year 2
5 secondary outcomes
Change from Baseline in Serum Bone Formation Markers (bone-specific alkaline phosphatase) at Year 1 and Year 2
Time frame: Baseline, year 1 and year 2
Change from Baseline in Bone Resorption Markers (C-telopeptide) at Year 1 and Year 2
Time frame: Baseline, year 1 and year 2
Change from Baseline in Serum 25-Hydroxy Vitamin D at Year 1 and Year 2
Time frame: Baseline, year 1 and year 2
Change from Baseline in Serum Interleukin-6 at Year 1 and Year 2
Time frame: Baseline, year 1 and year 2
Change from Baseline in C-reactive Protein at Year 1 and Year 2
Time frame: Baseline, year 1 and year 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 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.
Brenda J. Smith, Ph.D. principal investigator
Oklahoma State University
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 Osteoporosis, run by Oklahoma State University 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 19 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Bone Mineral Density at Year 1 and Year 2 (time frame: Baseline, year 1 and year 2). 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 19 Oct 2026.