The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study)

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborators: Aventis Pharmaceuticals; Procter and Gamble
• Treatments: Risedronate Sodium; Risedronic Acid

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