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| Sponsors and Collaborators: |
University of Pittsburgh Procter and Gamble Aventis Pharmaceuticals |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00118508 |
Purpose
The purpose of this study is to evaluate the effectiveness of once weekly risedronate in the prevention and treatment of bone loss in premenopausal and newly menopausal women with breast cancer who have received chemotherapy.
The hypothesis is that bisphosphonate therapy will prevent bone loss at clinically relevant sites, such as the hip and spine. The investigators also hypothesize that there will be a correlation between biochemical markers of bone turnover and changes in bone mineral density.
| Condition | Intervention |
|---|---|
|
Osteoporosis |
Drug: risedronate (including placebo) |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study) |
| Enrollment: | 87 |
| Study Start Date: | May 2003 |
| Estimated Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Placebo Comparator
Group A will receive active study drug
|
Drug: risedronate (including placebo)
risedronate 35mg weekly
|
Breast cancer is a significant public health problem accounting for approximately 30% of new cancers diagnosed annually. Much advancement has been made in the treatment of these cancers which has significantly decreased the mortality rates. Treatment, including adjuvant chemotherapy and hormonal therapy, prolongs disease free survival and overall survival of patients with breast cancer. The cytotoxic drugs, however, can cause premature ovarian failure and subsequent menopause. This risk has been reported to range from 53% to 89%. Temporary or permanent chemotherapy induced ovarian failure is important because of potential bone loss associated with the estrogen loss. Initiating a potent antiresorptive agent, risedronate, should prevent or improve bone mass in these women.
Comparison: The investigators will compare bone mass/markers of study subjects receiving risedronate with study subjects receiving placebo. All subjects will be provided calcium and vitamin D supplementation as needed.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Medical Center (GCRC) | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Susan L Greenspan, MD | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh ( Susan L. Greenspan, MD (Principal Investigator) ) |
| Study ID Numbers: | IRB#0404173 |
| Study First Received: | June 30, 2005 |
| Last Updated: | June 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00118508 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Calcium, Dietary Musculoskeletal Diseases Skin Diseases Calcium Channel Blockers Osteoporosis Breast Neoplasms |
Bone Density Conservation Agents Bone Diseases, Metabolic Cardiovascular Agents Bone Diseases Risedronic acid Breast Diseases |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Physiological Effects of Drugs Calcium Channel Blockers Breast Neoplasms Osteoporosis Bone Diseases, Metabolic Bone Density Conservation Agents Cardiovascular Agents |
Bone Diseases Pharmacologic Actions Membrane Transport Modulators Neoplasms Neoplasms by Site Musculoskeletal Diseases Therapeutic Uses Breast Diseases Risedronic acid |
