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Oklahoma Native American Women's Osteoporosis Screening Study

Oklahoma Native American Women's Osteoporosis Screening Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01939470
Enrollment
301
Registered
2013-09-11
Start date
2007-10-31
Completion date
2011-03-31
Last updated
2019-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

osteoporosis, bone, inflammation, diabetes, vitamin D

Brief 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 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.

Interventions

None listed

Sponsors

Oklahoma State University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Native American women who are eligible fore services at Indian Health Clinics in OKC * 50 years of age or older

Exclusion criteria

* Women who weigh more than 300 lbs or who are pregnant or cognitively impaired

Design outcomes

Primary

MeasureTime frame
Change from Baseline in Bone Mineral Density at Year 1 and Year 2Baseline, year 1 and year 2

Secondary

MeasureTime frame
Change from Baseline in Serum Bone Formation Markers (bone-specific alkaline phosphatase) at Year 1 and Year 2Baseline, year 1 and year 2
Change from Baseline in Bone Resorption Markers (C-telopeptide) at Year 1 and Year 2Baseline, year 1 and year 2
Change from Baseline in Serum 25-Hydroxy Vitamin D at Year 1 and Year 2Baseline, year 1 and year 2
Change from Baseline in Serum Interleukin-6 at Year 1 and Year 2Baseline, year 1 and year 2
Change from Baseline in C-reactive Protein at Year 1 and Year 2Baseline, year 1 and year 2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026