Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss

Alendronate to Prevent Perimenopausal Transition Bone Loss

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.

Study Overview

• Status: Completed
• Conditions: Perimenopausal Bone Loss
• Intervention / Treatment: Drug: Fosamax

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 54 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Perimenopausal women

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Robert B. Jaffe, M.D., University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: September 16, 2005
• First Submitted That Met QC Criteria: September 16, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): May 8, 2008
• Last Update Submitted That Met QC Criteria: May 5, 2008
• Last Verified: May 1, 2005

More Information

Terms related to this study

• Keywords: Perimenopausal bone loss
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate
• Other Study ID Numbers: H675-20192; H675-20192-05; 39-62