Trial record 2 of 22 for:    native american AND (woman OR women OR female)

Oklahoma Native American Women's Osteoporosis Screening Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oklahoma State University
ClinicalTrials.gov Identifier:
NCT01939470
First received: August 1, 2013
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.


Condition
Osteoporosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oklahoma Native American Women's Osteoporosis Screening Study

Resource links provided by NLM:


Further study details as provided by Oklahoma State University:

Primary Outcome Measures:
  • Change from Baseline in Bone Mineral Density at Year 1 and Year 2 [ Time Frame: Baseline, year 1 and year 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change from Baseline in Bone Resorption Markers (C-telopeptide) at Year 1 and Year 2 [ Time Frame: Baseline, year 1 and year 2 ] [ Designated as safety issue: No ]
  • Change from Baseline in Serum 25-Hydroxy Vitamin D at Year 1 and Year 2 [ Time Frame: Baseline, year 1 and year 2 ] [ Designated as safety issue: No ]
  • Change from Baseline in Serum Interleukin-6 at Year 1 and Year 2 [ Time Frame: Baseline, year 1 and year 2 ] [ Designated as safety issue: No ]
  • Change from Baseline in C-reactive Protein at Year 1 and Year 2 [ Time Frame: Baseline, year 1 and year 2 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 301
Study Start Date: October 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Native American Women
Native American Women over the age of 50 yrs

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01939470

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117
Sponsors and Collaborators
Oklahoma State University
Investigators
Principal Investigator: Brenda J. Smith, Ph.D. Oklahoma State University
  More Information

No publications provided

Responsible Party: Oklahoma State University
ClinicalTrials.gov Identifier: NCT01939470     History of Changes
Other Study ID Numbers: HE0840
Study First Received: August 1, 2013
Last Updated: September 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma State University:
osteoporosis
bone
inflammation
diabetes
vitamin D

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 14, 2014