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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis

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 Type: Observational
• Enrollment (Actual): 301

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Community sample of Native American who are eligible for health care services at Indian Health Clinics in the Oklahoma City area

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Native American Women; Native American Women over the age of 50 yrs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Bone Mineral Density at Year 1 and Year 2	Baseline, year 1 and year 2

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oklahoma State University
• Investigators: Principal Investigator: Brenda J. Smith, Ph.D., Oklahoma State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2007
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: September 5, 2013
• First Posted (ESTIMATE): September 11, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: diabetes; osteoporosis; inflammation; bone; vitamin D
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: HE0840