The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study)
1 other identifier
interventional
87
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2003
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedAugust 13, 2015
August 1, 2015
3.2 years
June 30, 2005
August 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
24 months
Secondary Outcomes (1)
There will be a correlation between biochemical markers of bone turnover and changes in BMD.
24 months
Study Arms (1)
A
PLACEBO COMPARATORGroup A will receive active study drug
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Procter and Gamblecollaborator
- Aventis Pharmaceuticalscollaborator
Study Sites (1)
University of Pittsburgh Medical Center (GCRC)
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (2)
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.
PMID: 38979716DERIVEDGreenspan 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: 18427147DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan L Greenspan, MD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 11, 2005
Study Start
May 1, 2003
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
August 13, 2015
Record last verified: 2015-08