Clinical trial · Interventional
The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study)
NCT00118508CI-TRIAL-00018837completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| risedronate (including placebo) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- PLACEBO_COMPARATOR
- label
- A
- description
- Group A will receive active study drug
- interventionNames
- Drug: risedronate (including placebo)
Primary outcomes (1)
- 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.
- timeFrame
- 24 months
Secondary outcomes (1)
- measure
- There will be a correlation between biochemical markers of bone turnover and changes in BMD.
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDAdams 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. PMID 38979716
- DERIVEDGreenspan 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. PMID 18427147