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

Completed

• Conditions: Postmenopausal Osteoporosis

• Registration Number: NCT00778154
• Lead Sponsor: Warner Chilcott

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-23
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-03
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in iliac crest bone histomorphometry and bone quality 9microarchitecture and matrix structure in PMO women receiving long term therapy with alendronate or risedronate	one year

Secondary Outcome Measures

Name	Time	Method
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	one year

Trial Locations

Locations (1)

Warner Chilcott Research Facility; 🇨🇦 Montreal, Quebec, Canada