Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Alendronate or Risedronate
Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Osteoporosis
Phase: N/A
Status: Completed
Sponsored by: Warner Chilcott Official(s) and/or principal investigator(s):
Stephen R Marcello, MD, Study Director, Affiliation: Procter and Gamble
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 the hip by DXA. Each patient will receive tetracycline to label
the bone and then have a transiliac bone biopsy. One year later teh bone label and biopsy
procedure will be repeated.
Clinical Details
Official title: A Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Long-Term Alendronate or Risedronate
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Differences in iliac crest bone histomorphometry and bone quality 9microarchitecture and matrix structure in PMO women receiving long term therapy with alendronate or risedronate
Secondary outcome: Compare iliac crest bone histomorphometry and bone quality changes after 5 years of more of alendronate or risedronate therapy with 3 years of therapy in PMO women
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Warner Chilcott Research Facility, Palm Desert, California 92269, United States
Warner Chilcott Research Facility, Lakewood, Colorado 80227, United States
Warner Chilcott Research Facility, Decatur, Georgia 30033, United States
Warner Chilcott Research Facility, Gainesville, Georgia 30501, United States
Warner Chilcott Research Facility, Omaha, Nebraska 68131, United States
Warner Chilcott Research Facility, Cincinnati, Ohio 45219, United States
Warner Chilcott Research Facility, Wyomissing, Pennsylvania 19610, United States
Warner Chilcott Research Facility, Montreal, Quebec H2X 1P1, Canada
Additional Information
Starting date: January 2004
Last updated: June 3, 2013
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