Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss
Completed
Conditions studied: Perimenopausal Bone Loss
In brief
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.
Key facts
- Study ID
- NCT00221312
- Run by
- University of California, San Francisco
- People needed
- 48
- Starts
- 2002-05-01
- Expected to finish
- 2007-07-01
- Last updated by the study team
- 2008-05-08
Who can join
Age: 40 and older, up to 54. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Women ages 40-54 with symptomology of perimenopause including hot flashes, irregular periods and vaginal dryness.
You may not qualify if…
- 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.
Where it is running
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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