The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study)
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2003 |
| End Date: | July 2006 |
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
