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Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss

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ClinicalTrials.gov Identifier: NCT00221312
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 8, 2008
Sponsor:
Information provided by:
University of California, San Francisco

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
Perimenopausal Bone Loss Drug: Fosamax

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 2002
Actual Study Completion Date : July 2007

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Ages Eligible for Study:   40 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Perimenopausal women
Criteria

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221312


Locations
United States, California
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

Responsible Party: Robert Jaffe, M.D., UCaliforniaSF
ClinicalTrials.gov Identifier: NCT00221312     History of Changes
Other Study ID Numbers: H675-20192
H675-20192-05
39-62
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 8, 2008
Last Verified: May 2005

Keywords provided by University of California, San Francisco:
Perimenopausal bone loss

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs