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Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00221312
First received: September 16, 2005
Last updated: May 5, 2008
Last verified: May 2005
History of Changes
  Purpose

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.


Condition Intervention
Perimenopausal Bone Loss
 Drug: Fosamax

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Alendronate to Prevent Perimenopausal Transition Bone Loss

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:
Enrollment: 48
Study Start Date: May 2002
Study Completion Date: July 2007
  Eligibility
Ages Eligible for Study:   40 Years to 54 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Perimenopausal women

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221312

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Robert B. Jaffe, M.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: Robert Jaffe, M.D., UCaliforniaSF
ClinicalTrials.gov Identifier: NCT00221312     History of Changes
Other Study ID Numbers: H675-20192, H675-20192-05, 39-62
Study First Received: September 16, 2005
Last Updated: May 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Perimenopausal bone loss

ClinicalTrials.gov processed this record on March 03, 2015