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...
Date First Received: September 16, 2005
Last Updated: May 5, 2008
Verified by: University of California, San Francisco, May 2005
Clinical Trial Phase: N/A | Start Date: May 2002
Overall Status: Completed
Estimated Enrollment: 48
Brief Summary
Official Title: “Alendronate to Prevent Perimenopausal Transition Bone Loss”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Observational
Study Design: Case Control, Prospective
Intervention(s) in this Clinical Trial
- Drug: Fosamax
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: 54 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University of California, San Francisco
Overall Clinical Trial Officials and Contacts
Robert B. Jaffe, M.D. Principal Investigator University of California, San Francisco
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00221312
Study ID Number: H675-20192
ClinicalTrials.gov Identifier: NCT00221312
Health Authority: United States: Institutional Review Board
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