Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss

Completed

• Conditions: Perimenopausal Bone Loss

• Registration Number: NCT00221312
• Lead Sponsor: University of California, San Francisco

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Status Verified: 2005-05
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Study Completion: 2007-07
• Last Update Submitted: 2008-05-05
• Last Update Posted: 2008-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States