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

Phase 4

Completed

Conditions: Bone Loss
Osteoporosis
Breast Cancer

Interventions: Drug: risedronate

Registration Number: NCT00485953

Lead Sponsor: Susan L. Greenspan

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 109

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Medication Group	risedronate	risedronate 35 mg weekly

Primary Outcome Measures

Name	Time	Method
BMD of Spine by DXA	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

Name	Time	Method
BMD by DXA at the Femoral Neck and Total Hip	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.
Markers of Bone Resorption and Bone Formation	at 24 months