Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss
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| ClinicalTrials.gov Identifier: NCT00221312 |
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Recruitment Status
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Completed
First Posted
: September 22, 2005
Last Update Posted
: May 8, 2008
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Perimenopausal Bone Loss | Drug: Fosamax |
| Study Type : | Observational |
| Actual Enrollment : | 48 participants |
| Observational Model: | Case Control |
| Time Perspective: | Prospective |
| Official Title: | Alendronate to Prevent Perimenopausal Transition Bone Loss |
| Study Start Date : | May 2002 |
| Actual Study Completion Date : | July 2007 |
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| Ages Eligible for Study: | 40 Years to 54 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221312
| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: | Robert B. Jaffe, M.D. | University of California, San Francisco |
| 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 |
| First Posted: | September 22, 2005 Key Record Dates |
| Last Update Posted: | May 8, 2008 |
| Last Verified: | May 2005 |
Keywords provided by University of California, San Francisco:
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Perimenopausal bone loss |
Additional relevant MeSH terms:
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Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |
Alendronate Bone Density Conservation Agents Physiological Effects of Drugs |