Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss

Perimenopausal Bone Loss Clinical Trial

Official title:

Alendronate to Prevent Perimenopausal Transition Bone Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221312
• Other study ID #: H675-20192
• Secondary ID: H675-20192-0539-
• Status: Completed
• Phase: N/A
• First received: September 16, 2005
• Last updated: May 5, 2008
• Start date: May 2002
• Est. completion date: July 2007

Study information

• Verified date: May 2005
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 54 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Perimenopausal Bone Loss

Intervention

Drug:
• Fosamax

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States,