The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study)
18 Years
N/A
Female
Osteoporosis
Trial Information
The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
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.
Outcome Time Frame:
24 months
Safety Issue:
No
Principal Investigator
Susan L Greenspan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Pittsburgh
Authority:
United States: Institutional Review Board
Study ID:
IRB#0404173
NCT ID:
NCT00118508
Start Date:
May 2003
Completion Date:
July 2006
Related Keywords:
- Osteoporosis
- Breast Neoplasms
- Osteoporosis
Name | Location |
|---|---|
| University of Pittsburgh Medical Center (GCRC) | Pittsburgh, Pennsylvania 15213 |
