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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00485953
First received: June 11, 2007
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Bone Loss
Osteoporosis
Breast Cancer
Drug: risedronate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • BMD of Spine by DXA [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    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 Hip [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
  • Markers of Bone Resorption and Bone Formation [ Time Frame: at 24 months ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: September 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Medication Group
risedronate 35 mg weekly
Drug: risedronate
risedronate 35 mg per week
Other Name: Actonel
No Intervention: Placebo Group
Placebo

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485953

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Susan L. Greenspan, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00485953     History of Changes
Other Study ID Numbers: PRO06080002 (REBBeCA II)
Study First Received: June 11, 2007
Results First Received: June 2, 2014
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Osteoporosis
breast cancer
aromatase inhibitors
bone loss
bone mineral density

Additional relevant MeSH terms:
Breast Neoplasms
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Breast Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Aromatase Inhibitors
Diphosphonates
Risedronic acid
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014