drugset / Trial / NCT00118508
The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study)
Completed
87 enrolled
University of Pittsburgh
Aventis Pharmaceuticals · collabProcter and Gamble · collab
RandomizedSingle-groupTriple-blindPrevention
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.
Timeline
- Start
- 2003-05
- Primary completion
- 2006-07
- Completion
- 2006-07
Publications
- Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
- 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. doi: 10.1200/JCO.2007.15.2967. Epub 2008 Apr 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Risedronate | Small molecule | 35 mg | — |