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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00778154
First received: October 21, 2008
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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.


Condition
Postmenopausal Osteoporosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Long-Term Alendronate or Risedronate

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Differences in iliac crest bone histomorphometry and bone quality 9microarchitecture and matrix structure in PMO women receiving long term therapy with alendronate or risedronate [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

bone biopsies


Enrollment: 105
Study Start Date: January 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
Alendronate 3 to < 5 years
Alendronate (any combination of 10 mg daily or 70 mg once weekly) 3- 5 years.
Risedronate 3 to < 5 Years
Risedronate (any combination of 5 mg daily or 35 mg once weekly) 3-5 years.
Alendronate ≥ 5 Years
Alendronate (any combination of 10 mg daily or 70 mg once weekly) for greater than or equal to 5 years.
Risedronate ≥ 5 Years
Risedronate (any combination of 5 mg daily or 35 mg once weekly) for greater than or equal to 5 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Outpatients from bone research centers who have taken alendronate or risedronate for 3 to 5 or more years

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778154

Locations
United States, California
Warner Chilcott Research Facility
Palm Desert, California, United States, 92269
United States, Colorado
Warner Chilcott Research Facility
Lakewood, Colorado, United States, 80227
United States, Georgia
Warner Chilcott Research Facility
Decatur, Georgia, United States, 30033
Warner Chilcott Research Facility
Gainesville, Georgia, United States, 30501
United States, Nebraska
Warner Chilcott Research Facility
Omaha, Nebraska, United States, 68131
United States, Ohio
Warner Chilcott Research Facility
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Warner Chilcott Research Facility
Wyomissing, Pennsylvania, United States, 19610
Canada, Quebec
Warner Chilcott Research Facility
Montreal, Quebec, Canada, H2X 1P1
Sponsors and Collaborators
Warner Chilcott
Sanofi
Investigators
Study Director: Stephen R Marcello, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00778154     History of Changes
Obsolete Identifiers: NCT00778635
Other Study ID Numbers: 2003096
Study First Received: October 21, 2008
Last Updated: June 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Alendronate
Risedronic acid
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014