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

Postmenopausal Osteoporosis Clinical Trial

Official title:

A Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Long-Term Alendronate or Risedronate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778154
• Other study ID #: 2003096
• Status: Completed
• Phase: N/A
• First received: October 21, 2008
• Last updated: June 3, 2013
• Start date: January 2004
• Est. completion date: December 2006

Study information

• Verified date: June 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT00778635

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Locations

Country	Name	City	State
Canada	Warner Chilcott Research Facility	Montreal	Quebec
United States	Warner Chilcott Research Facility	Cincinnati	Ohio
United States	Warner Chilcott Research Facility	Decatur	Georgia
United States	Warner Chilcott Research Facility	Gainesville	Georgia
United States	Warner Chilcott Research Facility	Lakewood	Colorado
United States	Warner Chilcott Research Facility	Omaha	Nebraska
United States	Warner Chilcott Research Facility	Palm Desert	California
United States	Warner Chilcott Research Facility	Wyomissing	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Warner Chilcott	Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No