Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss
Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Perimenopausal Bone Loss
Intervention: Fosamax (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
Robert B. Jaffe, M.D., Principal Investigator, Affiliation: University of California, San Francisco
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.
Clinical Details
Official title: Alendronate to Prevent Perimenopausal Transition Bone Loss
Study design: Observational Model: Case Control, Time Perspective: Prospective
Eligibility
Minimum age: 40 Years.
Maximum age: 54 Years.
Gender(s): Female.
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.
Locations and Contacts
University of California, San Francisco, San Francisco, California 94143, United States
Additional Information
Starting date: May 2002
Last updated: May 5, 2008
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