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Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss

NCT ID: NCT00221312

Last Updated: 2008-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-05-31

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Perimenopausal Bone Loss

Keywords

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Perimenopausal bone loss

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Fosamax

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

54 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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UCaliforniaSF

Principal Investigators

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Robert B. Jaffe, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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H675-20192-05

Identifier Type: -

Identifier Source: secondary_id

39-62

Identifier Type: -

Identifier Source: secondary_id

H675-20192

Identifier Type: -

Identifier Source: org_study_id