Oklahoma Native American Women's Osteoporosis Screening Study

Osteoporosis Clinical Trial

Official title:

Oklahoma Native American Women's Osteoporosis Screening Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939470
• Other study ID #: HE0840
• Status: Completed
• Start date: October 2007
• Est. completion date: March 2011

Study information

• Verified date: March 2019
• Source: Oklahoma State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Bone Mineral Density at Year 1 and Year 2		Baseline, year 1 and year 2
Secondary	Change from Baseline in Serum Bone Formation Markers (bone-specific alkaline phosphatase) at Year 1 and Year 2		Baseline, year 1 and year 2
Secondary	Change from Baseline in Bone Resorption Markers (C-telopeptide) at Year 1 and Year 2		Baseline, year 1 and year 2
Secondary	Change from Baseline in Serum 25-Hydroxy Vitamin D at Year 1 and Year 2		Baseline, year 1 and year 2
Secondary	Change from Baseline in Serum Interleukin-6 at Year 1 and Year 2		Baseline, year 1 and year 2
Secondary	Change from Baseline in C-reactive Protein at Year 1 and Year 2		Baseline, year 1 and year 2