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Bone Health of People With Cystic Fibrosis

Sponsor
National Center for Research Resources (NCRR) (NIH)
Overall Status
Completed
CT.gov ID
NCT00008762
Collaborator
Cystic Fibrosis Foundation (Other)
1
Location

Study Details

Study Description

Brief Summary

People with cystic fibrosis (CF) now frequently live into adulthood and with this extended life expectancy has come new clinical problems. Poor bone health, including osteoporosis and bone fractures, is one of these increasingly important conditions. Preventing the negative outcomes of poor bone health in later life is primarily related to ensuring optimal growth (weight and height) and obtaining maximal amount of bone mass during growth and development. This study will identify factors that influence bone health in a sample of children, adolescents and young adults as measured by dual energy x-ray absorptiometry and new bone densitometry methods (peripheral quantitative computerized tomography [p-QCT] and bone sonometer). We will also identify factors which influence changes in bone status over a 12-month follow-up period in a subsample of people with CF.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A total of 100 subjects with CF and pancreatic insufficiency (8-25 y, half female) will be recruited from the Children's Hospital of Philadelphia (CHOP) and the Delaware Valley region. All subjects will have baseline measurements obtained at the Nutrition and Growth Lab at CHOP. A subset of subjects will return for 12-month follow-up measurements.

    We will evaluate the influences on bone health, including: gender, stage of pubertal development, body weight and height, food intake (especially calcium and vitamin D), use of steroid medications by mouth, IV administration or inhalation, physical activity and lung health. We will also follow the changes in bone health and growth over 12 months, and see what factors are associated with good and poor bone development.

    In addition, the information from this study will be very important to planning the future trials of medication and other interventions to treat and, hopefully, to prevent poor bone health in people with CF.

    Study Design

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Other
    Official Title:
    Bone Health of People With Cystic Fibrosis

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      8 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion:

      • Diagnosis of cystic fibrosis with pancreatic insufficiency

      • FEV-1 ? 40% predicted

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104

      Sponsors and Collaborators

      • National Center for Research Resources (NCRR)
      • Cystic Fibrosis Foundation

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00008762
      Other Study ID Numbers:
      • NCRR-M01RR00240-1742
      First Posted:
      Jan 18, 2001
      Last Update Posted:
      Jun 24, 2005
      Last Verified:
      Dec 1, 2003
      Additional relevant MeSH terms:
      Cystic Fibrosis
      Fibrosis

      Study Results

      No Results Posted as of Jun 24, 2005