Expired Study
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Pittsburgh, Pennsylvania 15213


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

IRB#0404173


NCT ID:

NCT00118508


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

87


Enrollment Type:

Actual


Overall Contact Information

Official Name:Susan L Greenspan, MD
Principal Investigator
University of Pittsburgh

Study Dates

Start Date:May 2003
Completion Date:July 2006
Completion Type:Actual
Primary Completion Date:July 2006
Primary Completion Type:Actual
Verification Date:August 2015
Last Changed Date:August 10, 2015
First Received Date:June 30, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:There will be a correlation between biochemical markers of bone turnover and changes in BMD.
Time Frame:24 months
Safety Issues:False
Outcome Type:Primary Outcome
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.
Time Frame:24 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:risedronate (including placebo)
Description:risedronate 35mg weekly
Arm Name:A
Other Name:Actonel

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:A
Description:Group A will receive active study drug

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pittsburgh
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Procter and Gamble

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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