The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study)
Overview
- Phase
- Not Applicable
- Intervention
- risedronate (including placebo)
- Conditions
- Osteoporosis
- Sponsor
- University of Pittsburgh
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
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.
Investigators
Susan L. Greenspan
Principal Investigator
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •Pre- and newly postmenopausal (up to 8 years) women ages 18 and older
- •Breast cancer treated with chemotherapeutic agents, with or without tamoxifen/aromatase inhibitors
- •Negative pregnancy test
Exclusion Criteria
- •Stage 4 breast cancer
- •Any illness or medications known to affect bone metabolism
- •History of osteoporosis or history of vertebral or hip fractures
- •Kidney stones in the past 5 years
- •Active peptic ulcer disease
Arms & Interventions
A
Group A will receive active study drug
Intervention: risedronate (including placebo)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- There will be a correlation between biochemical markers of bone turnover and changes in BMD.(24 months)