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OpenTrials
Completed

NCT Number: NCT00221312

Fosamax Bone Loss Study: Alendronate to Prevent 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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Key information

Age range

40 year–54 year

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fosamax

Drug

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Alendronate to Prevent Perimenopausal Transition Bone Loss

Important dates

Study start
2002
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
May 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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