Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy
Condition: Bone Loss; Osteoporosis; Breast Cancer
MeSH terms: Breast Neoplasms; Osteoporosis
Intervention: risedronate
Intervention description: risedronate 35 mg per week
Intervention MeSH terms: Risedronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 109.0
Sex: Female
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Osteoporosis; breast cancer; aromatase inhibitors; bone loss; bone mineral density

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.
    

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