Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Alendronate or Risedronate

Completed

Conditions studied: Postmenopausal Osteoporosis

In brief

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.

Key facts

Study ID

NCT00778154

Run by

Warner Chilcott

People needed

105

Starts

2004-01-01

Expected to finish

2006-12-01

Last updated by the study team

2013-06-05

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Warner Chilcott Research Facility — Palm Desert, California, United States
• Warner Chilcott Research Facility — Lakewood, Colorado, United States
• Warner Chilcott Research Facility — Decatur, Georgia, United States
• Warner Chilcott Research Facility — Gainesville, Georgia, United States
• Warner Chilcott Research Facility — Omaha, Nebraska, United States
• Warner Chilcott Research Facility — Cincinnati, Ohio, United States
• Warner Chilcott Research Facility — Wyomissing, Pennsylvania, United States
• Warner Chilcott Research Facility — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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