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Completed

NCT Number: NCT01939470

Oklahoma Native American Women's Osteoporosis Screening 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.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change from Baseline in Bone Mineral Density at Year 1 and Year 2

    Time frame: Baseline, year 1 and year 2

Secondary outcomes

  1. 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

  2. Change from Baseline in Bone Resorption Markers (C-telopeptide) at Year 1 and Year 2

    Time frame: Baseline, year 1 and year 2

  3. Change from Baseline in Serum 25-Hydroxy Vitamin D at Year 1 and Year 2

    Time frame: Baseline, year 1 and year 2

  4. Change from Baseline in Serum Interleukin-6 at Year 1 and Year 2

    Time frame: Baseline, year 1 and year 2

  5. Change from Baseline in C-reactive Protein at Year 1 and Year 2

    Time frame: Baseline, year 1 and year 2

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 11, 2013
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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