Overview

This trial is active, not recruiting.

Condition osteoporosis
Sponsor Oklahoma State University
Start date October 2007
End date March 2011
Trial size 301 participants
Trial identifier NCT01939470, HE0840

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Native American Women over the age of 50 yrs

Primary Outcomes

Measure
Change from Baseline in Bone Mineral Density at Year 1 and Year 2
time frame: Baseline, year 1 and year 2

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 50 years old.

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

Additional Information

Official title Oklahoma Native American Women's Osteoporosis Screening Study
Principal investigator Brenda J. Smith, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Oklahoma State University.