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

September 16, 2005
May 5, 2008
May 2002
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Complete list of historical versions of study NCT00221312 on ClinicalTrials.gov Archive Site
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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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Perimenopausal women

Perimenopausal Bone Loss
Drug: Fosamax
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
July 2007
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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.
Female
40 Years to 54 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00221312
H675-20192, H675-20192-05, 39-62
No
Robert Jaffe, M.D., UCaliforniaSF
University of California, San Francisco
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Principal Investigator: Robert B. Jaffe, M.D. University of California, San Francisco
University of California, San Francisco
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP