The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study)
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| First Received Date ICMJE | June 30, 2005 | ||||
| Last Updated Date | February 8, 2013 | ||||
| Start Date ICMJE | May 2003 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
That bone loss, as determined through BMD every six months, will be prevented at clinically relevant sites, such as the hip & spine, through the use of bisphosphonate therapy in study subjects. [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00118508 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
There will be a correlation between biochemical markers of bone turnover and changes in BMD. [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study) | ||||
| Official Title ICMJE | The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study) | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
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| Condition ICMJE | Osteoporosis | ||||
| Intervention ICMJE | Drug: risedronate (including placebo)
risedronate 35mg weekly
Other Name: Actonel |
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| Study Arm (s) | Placebo Comparator: A
Group A will receive active study drug
Intervention: Drug: risedronate (including placebo) |
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| Publications * | Greenspan SL, Brufsky A, Lembersky BC, Bhattacharya R, Vujevich KT, Perera S, Sereika SM, Vogel VG. Risedronate prevents bone loss in breast cancer survivors: a 2-year, randomized, double-blind, placebo-controlled clinical trial. J Clin Oncol. 2008 Jun 1;26(16):2644-52. Epub 2008 Apr 21. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 87 | ||||
| Completion Date | July 2006 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00118508 | ||||
| Other Study ID Numbers ICMJE | IRB#0404173 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Susan L. Greenspan, MD (Principal Investigator), University of Pittsburgh | ||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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