Status:
COMPLETED
Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss
Lead Sponsor:
University of California, San Francisco
Conditions:
Perimenopausal Bone Loss
Eligibility:
FEMALE
40-54 years
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 effe...
Eligibility Criteria
Inclusion
- Women ages 40-54 with symptomology of perimenopause including hot flashes, irregular periods and vaginal dryness.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00221312
Start Date
May 1 2002
End Date
July 1 2007
Last Update
May 8 2008
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143