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Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00221312
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 8, 2008
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

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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

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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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

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00221312

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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Robert B. Jaffe, M.D. University of California, San Francisco
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Responsible Party: Robert Jaffe, M.D., UCaliforniaSF Identifier: NCT00221312    
Other Study ID Numbers: H675-20192
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:
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Bone Diseases, Metabolic
Osteoporosis, Postmenopausal
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs