Working… Menu
Trial record 1 of 1 for:    REBBeCA II
Previous Study | Return to List | Next Study

Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy (REBBeCA II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485953
Recruitment Status : Completed
First Posted : June 13, 2007
Results First Posted : July 3, 2014
Last Update Posted : October 13, 2017
University of Pittsburgh
Information provided by (Responsible Party):
Susan L. Greenspan, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Bone Loss Osteoporosis Breast Cancer Drug: risedronate Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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 Start Date : September 2007
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Active Medication Group
risedronate 35 mg weekly
Drug: risedronate
risedronate 35 mg per week
Other Name: Actonel

No Intervention: Placebo Group

Primary Outcome Measures :
  1. BMD of Spine by DXA [ Time Frame: at 24 months ]
    BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.

Secondary Outcome Measures :
  1. BMD by DXA at the Femoral Neck and Total Hip [ Time Frame: at 24 months ]
    BMD is the bone mineral density of the femoral neck and total hip measured using the dual-energy x-ray absorptiometry (DXA) scan.

  2. Markers of Bone Resorption and Bone Formation [ Time Frame: at 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00485953

Layout table for location information
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Susan L. Greenspan
University of Pittsburgh
Layout table for investigator information
Principal Investigator: Susan L. Greenspan, MD University of Pittsburgh
Layout table for additonal information
Responsible Party: Susan L. Greenspan, Professor, University of Pittsburgh Identifier: NCT00485953    
Other Study ID Numbers: PRO06080002 (REBBeCA II)
First Posted: June 13, 2007    Key Record Dates
Results First Posted: July 3, 2014
Last Update Posted: October 13, 2017
Last Verified: September 2017
Keywords provided by Susan L. Greenspan, University of Pittsburgh:
breast cancer
aromatase inhibitors
bone loss
bone mineral density
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents