Oklahoma Native American Women's Osteoporosis Screening Study

NCT01939470 | Completed

• 1 other identifier: HE0840
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

osteoporosis; bone; inflammation; diabetes; vitamin D

Outcome Measures

Primary Outcomes (1)

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

  Baseline, year 1 and year 2

Secondary Outcomes (5)

• 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

Study Arms (1)

Native American Women

Native American Women over the age of 50 yrs

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oklahoma State University: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Osteoporosis; Inflammation; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Brenda J. Smith, Ph.D.

  Oklahoma State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: September 11, 2013
• Study Start: October 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

US (1)