Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss

NCT00221312 | Completed

• 3 other identifiers: H675-20192H675-20192-0539-62
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perimenopausal Bone Loss

Keywords

Perimenopausal bone loss

Interventions

Fosamax DRUG

Eligibility Criteria

• Age: 40 Years - 54 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Perimenopausal women

You may qualify if:

• Women ages 40-54 with symptomology of perimenopause including hot flashes, irregular periods and vaginal dryness.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Robert B. Jaffe, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: May 1, 2002
• Study Completion: July 1, 2007
• Last Updated: May 8, 2008

Record last verified: 2005-05

Locations

US (1)