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Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT00221312
Collaborator
(none)
48
Enrollment
1
Location
62
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study to determine if Fosamax (alendronate), a medication approved by the Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in postmenopausal women, is effective in decreasing the rate of bone loss which often begins to increase in the three to five years preceding the menopause (perimenopausal transition).

During the three to five years prior to the menopause, the rate of bone loss increases. One way that physicians treat this is with oral contraceptive medication. However, the incidence of complications from oral contraceptives after the age of 40 increases. Therefore, a non-hormonal means of preventing bone loss should be useful. Fosamax (alendronate) is in a class of compounds called bisphosphonates. This study is being done to determine whether Fosamax can be used to prevent the increased rate of bone loss during the perimenopausal transition.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
48 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Alendronate to Prevent Perimenopausal Transition Bone Loss
Study Start Date :
May 1, 2002
Actual Study Completion Date :
Jul 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 54 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women ages 40-54 with symptomology of perimenopause including hot flashes, irregular periods and vaginal dryness.
    Exclusion Criteria:

    • Women should not be on hormone replacements, oral contraceptives, or bone mineral enhancing medications (bisphosphonates, selective estrogen receptor modulators [SERM's], parathyroid hormone [PTH], calcitriol, fluorides)

    • They should not have any abnormalities of the esophagus which delay esophageal emptying

    • They should not have hypocalcemia or severe kidney disease

    • Their bone mineral density (T-score) should not be greater than 2 standard deviations.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94143

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Robert B. Jaffe, M.D., University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00221312
    Other Study ID Numbers:
    • H675-20192
    • H675-20192-05
    • 39-62
    First Posted:
    Sep 22, 2005
    Last Update Posted:
    May 8, 2008
    Last Verified:
    May 1, 2005
    Keywords provided by , ,
    Perimenopausal bone loss
    Additional relevant MeSH terms:
    Bone Diseases, Metabolic
    Osteoporosis, Postmenopausal
    Alendronate

    Study Results

    No Results Posted as of May 8, 2008