Back to resultsEffect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy (REBBeCA II)
Primary Purpose
Bone Loss, Osteoporosis, Breast Cancer
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
risedronate
Sponsored by
About this trial
This is an interventional prevention trial for Bone Loss focused on measuring Osteoporosis, breast cancer, aromatase inhibitors, bone loss, bone mineral density
Eligibility Criteria
Inclusion Criteria:
- elderly postmenopausal women (ages 55 and older)
- osteopenic (DXA T-score -1.0 to -2.5 SD). However, after full counseling about the risks, benefits, and options regarding therapy for osteoporosis and discussion with her PCP, an osteoporotic woman may enroll in the study.
- with breast cancer on aromatase inhibitor therapy
- with no evidence of distant metastatic disease or osteoporosis (by BMD or clinical history)
- type of surgical procedure or addition of radiation therapy prior to this aromatase inhibitor therapy will not exclude patients
- Participants must provide voluntary, written informed consent to participate in the study, which includes understanding of the procedures, medications, and risks and benefits
Exclusion Criteria:
- Women with stage 4 breast cancer (presence of distant metastases)
- Women with normal bone density by DXA (T-score > -1.0 SD)bone density by DXA, except in the instance of a fragility fracture.
- Women with history of any illness known to affect bone and mineral metabolism, such as renal failure (estimated GFR <30), hepatic failure, malignancy (excluding breast cancer, treated superficial basal and squamous cell carcinoma and malignancies where the diagnosis itself or its treatment would not adversely affect bone metabolism), untreated primary hyperparathyroidism, and malabsorption.
- Women being treated with oral glucocorticoid therapy >3 months for suppression therapy, and certain anti-seizure medications which may adversely affect bone metabolism (phenobarbital, phenytoin, carbamazepine).
- Those with untreated active peptic ulcer disease
- Those with osteoporosis by BMD (T-score -2.5 SD at the spine or total hip) or a history of fragility fracture as an adult. However, as discussed above, osteoporotic women may elect to enroll in the study.
- Women treated with oral bisphosphonates or calcitonin for 3 months within the last year (3 month washout period)
- Men and children will be excluded because they do not get postmenopausal osteoporosis following treatment with an aromatase inhibitor
- Women with very poor dental hygiene (as assessed by the baseline dental exam) in need of dental extraction during the study
- Use of fluoride for more than 1 month ever (except for dental treatment)
- Less than 2 evaluable vertebrae
- Distant metastatic disease
Sites / Locations
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active Medication Group
Placebo Group
Arm Description
risedronate 35 mg weekly
Placebo
Outcomes
Primary Outcome Measures
BMD of Spine by DXA
BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.
Secondary Outcome Measures
BMD by DXA at the Femoral Neck and Total Hip
BMD is the bone mineral density of the femoral neck and total hip measured using the dual-energy x-ray absorptiometry (DXA) scan.
Markers of Bone Resorption and Bone Formation
Full Information
NCT ID
NCT00485953
First Posted
June 11, 2007
Last Updated
September 12, 2017
Sponsor
Susan L. Greenspan
Collaborators
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT00485953
Brief Title
Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy
Acronym
REBBeCA II
Official Title
The Effect of Bisphosphonate on Bone Mass and Bone Turnover in Elderly, Postmenopausal Women With Breast Cancer Following Initiation of Aromatase Inhibitor Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susan L. Greenspan
Collaborators
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Elderly, postmenopausal women with breast cancer on aromatase inhibitors are at increased risk of developing bone loss and osteoporosis. We postulate that in elderly, osteopenic postmenopausal women who are on aromatase inhibitor therapy, bisphosphonate therapy will (1) prevent bone loss at clinically relevant sites, such as the spine and hip and (2) decrease bone turnover.
Detailed Description
This double-blind, placebo-controlled, randomized clinical trial will test the hypothesis that risedronate 35 mg once weekly, a potent antiresorptive agent, will prevent bone loss or improve bone mass and decrease bone turnover in elderly, osteopenic, postmenopausal women (ages 55 and older) with breast cancer on aromatase inhibitor therapy. 110 subjects will be randomized to receive either oral risedronate 35 mg once weekly or placebo for two years. Our primary outcome variable will be change in PA spine bone mineral density (BMD). Secondary endpoints will be BMD at the total hip, femoral neck, trochanter, lateral spine, forearm, and total body, and markers of bone turnover. We will also assess if the improvements in BMD are greater at sites of trabecular bone (spine) versus cortical bone (wrist). BMD will be measured at six month intervals. Biochemical markers of bone turnover will be measured at baseline, 6 months, 12 months, and 24 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Osteoporosis, Breast Cancer
Keywords
Osteoporosis, breast cancer, aromatase inhibitors, bone loss, bone mineral density
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Medication Group
Arm Type
Experimental
Arm Description
risedronate 35 mg weekly
Arm Title
Placebo Group
Arm Type
No Intervention
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
risedronate
Other Intervention Name(s)
Actonel
Intervention Description
risedronate 35 mg per week
Primary Outcome Measure Information:
Title
BMD of Spine by DXA
Description
BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.
Time Frame
at 24 months
Secondary Outcome Measure Information:
Title
BMD by DXA at the Femoral Neck and Total Hip
Description
BMD is the bone mineral density of the femoral neck and total hip measured using the dual-energy x-ray absorptiometry (DXA) scan.
Time Frame
at 24 months
Title
Markers of Bone Resorption and Bone Formation
Time Frame
at 24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
elderly postmenopausal women (ages 55 and older)
osteopenic (DXA T-score -1.0 to -2.5 SD). However, after full counseling about the risks, benefits, and options regarding therapy for osteoporosis and discussion with her PCP, an osteoporotic woman may enroll in the study.
with breast cancer on aromatase inhibitor therapy
with no evidence of distant metastatic disease or osteoporosis (by BMD or clinical history)
type of surgical procedure or addition of radiation therapy prior to this aromatase inhibitor therapy will not exclude patients
Participants must provide voluntary, written informed consent to participate in the study, which includes understanding of the procedures, medications, and risks and benefits
Exclusion Criteria:
Women with stage 4 breast cancer (presence of distant metastases)
Women with normal bone density by DXA (T-score > -1.0 SD)bone density by DXA, except in the instance of a fragility fracture.
Women with history of any illness known to affect bone and mineral metabolism, such as renal failure (estimated GFR <30), hepatic failure, malignancy (excluding breast cancer, treated superficial basal and squamous cell carcinoma and malignancies where the diagnosis itself or its treatment would not adversely affect bone metabolism), untreated primary hyperparathyroidism, and malabsorption.
Women being treated with oral glucocorticoid therapy >3 months for suppression therapy, and certain anti-seizure medications which may adversely affect bone metabolism (phenobarbital, phenytoin, carbamazepine).
Those with untreated active peptic ulcer disease
Those with osteoporosis by BMD (T-score -2.5 SD at the spine or total hip) or a history of fragility fracture as an adult. However, as discussed above, osteoporotic women may elect to enroll in the study.
Women treated with oral bisphosphonates or calcitonin for 3 months within the last year (3 month washout period)
Men and children will be excluded because they do not get postmenopausal osteoporosis following treatment with an aromatase inhibitor
Women with very poor dental hygiene (as assessed by the baseline dental exam) in need of dental extraction during the study
Use of fluoride for more than 1 month ever (except for dental treatment)
Less than 2 evaluable vertebrae
Distant metastatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L. Greenspan, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy
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