Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss
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...
Brief Summary
Official Title: “Alendronate to Prevent Perimenopausal Transition Bone Loss”
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: Observational Model: Case Control, Time Perspective: 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 Investigator Information
Lead Investigator: University of California, San Francisco Other
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 February 12, 2012
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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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00221312
