Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Alendronate or Risedronate
This study has been completed.
Sponsor:
Warner Chilcott
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
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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
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, Metabolic Bone Diseases Musculoskeletal Diseases Risedronic acid Alendronate Bone Density Conservation Agents |
Physiological Effects of Drugs Pharmacologic Actions Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013