Status:
COMPLETED
Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Alendronate or Risedronate
Lead Sponsor:
Warner Chilcott
Collaborating Sponsors:
Sanofi
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
Brief Summary
Patients who have received the appropriate number of years of alendronate or risedronate therapy will be recruited. Each patient will have received baseline BMD measurements performed at the spine and...
Eligibility Criteria
Inclusion
- Women at least 5 years postmenopausal
- Subjects treated with any combination alendronate 10 mg daily or 70 mg once weekly or any combination of risedronate 5mg daily or 35 mg weekly for 3-5 years. Or subjects treated with any combination of alendronate 10 mg daily or 70 mg once weekly or any combination of risedronate 5mg daily or 35 mg weekly for greater than 5 years.
Exclusion
- Presence of metabolic bone disease other than PMO
- Use of any medication other than alendronate or risedronate within with in the past 6 months likely to interfere with skeletal homeostasis.
- Uncontrolled hyperthyroidism. Previous history of malignancy except treated squamous cell or basal cell carcinoma of the skin.
- Alcohol or drug abuse, current or within the past 5 years.
- Allergy to tetracycline, Novocain, or Versed.
- Hip anatomy not conducive to transiliac bone biopsy or DXA scan.
- Previous bilateral transiliac bone biopsies.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00778154
Start Date
January 1 2004
End Date
December 1 2006
Last Update
June 5 2013
Active Locations (8)
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1
Warner Chilcott Research Facility
Palm Desert, California, United States, 92269
2
Warner Chilcott Research Facility
Lakewood, Colorado, United States, 80227
3
Warner Chilcott Research Facility
Decatur, Georgia, United States, 30033
4
Warner Chilcott Research Facility
Gainesville, Georgia, United States, 30501