Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Alendronate or Risedronate - Full Text View

Sponsors and Collaborators:	Procter and Gamble Sanofi-Aventis
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00778154

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:	Cohort, 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:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Alendronate Risedronic acid Alendronate sodium Fosamax

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

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

Biospecimen Description:

bone biopsies

Enrollment:	52
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
1 Postmenopausal women who have been treated with alendronate (any combination of 10 mg daily or 70 mg once weekly) for 3- 5 years.
2 Postmenopausal women who have been treated with risedronate (any combination of 5 mg daily or 35 mg once weekly) for 3-5 years.
3 Postmenopausal women who have been treated with alendronate (any combination of 10 mg daily or 70 mg once weekly) for greater than 5 years.
4 Postmenopausal women who have been treated with risedronate (any combination of 5 mg daily or 35 mg once weekly) for greater than years.

Eligibility

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

Study Population

Outpatients from two 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, Novacain, 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
Research Site
Palm Desert, California, United States
United States, Georgia
Research Site
Decatur, Georgia, United States
Research Site
Gainesville, Georgia, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Pennsylvania
Research Site
Wyomissing, Pennsylvania, United States
Canada, Quebec
Research Site
Montreal, Quebec, Canada

Sponsors and Collaborators

Procter and Gamble

Sanofi-Aventis

Investigators

Study Director:

Stephen R Marcello, MD

Procter and Gamble

More Information

No publications provided

Responsible Party:	Procter and Gamble Pharmaceuticals ( Ana Balske, MD )
Study ID Numbers:	2003096
Study First Received:	October 21, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00778154 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Calcium, Dietary
Musculoskeletal Diseases
Alendronate
Osteoporosis, Postmenopausal
Calcium Channel Blockers
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Cardiovascular Agents
Bone Diseases
Risedronic acid

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Osteoporosis
Calcium Channel Blockers
Bone Diseases, Metabolic
Bone Density Conservation Agents
Cardiovascular Agents
Bone Diseases

Pharmacologic Actions
Membrane Transport Modulators
Musculoskeletal Diseases
Alendronate
Therapeutic Uses
Osteoporosis, Postmenopausal
Risedronic acid

ClinicalTrials.gov processed this record on September 01, 2009