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:

Drug Information available for: Alendronate sodium

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 (Adult)
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


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

Additional relevant MeSH terms:


Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases	Alendronate Bone Density Conservation Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016

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