Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
- Conditions
- Breast CancerOsteoporosis
- Interventions
- Dietary Supplement: calcium carbonateDietary Supplement: vitamin DOther: placebo
- Registration Number
- NCT00054418
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss.
PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer.
- Detailed Description
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to planned tamoxifen therapy (yes vs no vs undecided), planned taxane therapy (yes vs no vs undecided), time from last menses (1-3 months vs longer than 3 months to 6 months), and age (under 40 vs 40 to 49 vs 50 and over). Patients are randomized to 1 of 2 treatment arms. In both arms, treatment begins during the first month of chemotherapy and continues for 1 year in the absence of unacceptable toxicity. For more information regarding the treatment arms, please see the "Arms" section below. Questionnaires about cessation of menses, ovarian failure, and menopausal symptoms are completed at baseline, monthly during chemotherapy, at 6 months, and then at 1 and 2 years.
Patients are followed for 1 year. A summary of study goals is listed below.
Goals:
1. To evaluate the effectiveness of risedronate at a weekly oral dose of 35 mg versus placebo in the prevention of bone loss in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.
2. To evaluate the degree of bone loss over one year in premenopausal women undergoing adjuvant chemotherapy for primary breast cancer according to menopausal status at one year after therapy begins.
3. To evaluate the relationship of current climacteric symptoms, menstrual and reproductive history, and chemotherapy regimen with ovarian failure (permanent cessation of menses) in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.
4. To evaluate the relationship of baseline serum estradiol levels with ovarian failure in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 216
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description calcium carbonate, vitamin D and risedronate calcium carbonate Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and risedronate 35 mg weekly. calcium carbonate, vitamin D and risedronate vitamin D Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and risedronate 35 mg weekly. calcium carbonate, vitamin D and placebo calcium carbonate Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and placebo weekly. calcium carbonate, vitamin D and placebo vitamin D Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and placebo weekly. calcium carbonate, vitamin D and placebo placebo Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and placebo weekly. calcium carbonate, vitamin D and risedronate risedronate sodium Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and risedronate 35 mg weekly.
- Primary Outcome Measures
Name Time Method Average intra-patient change in lumbar spine (L2-L4, PA) bone mineral density (BMD) from baseline to one year after study entry 1 year post study entry
- Secondary Outcome Measures
Name Time Method Average intra-patient change in femoral neck and total hip BMD from baseline to one year after study entry 1 year post study entry Incidence of osteopenia in the risedronate vs placebo groups at one year after study entry 1 year post study entry Incidence of osteoporosis in the risedronate vs placebo groups at one year after study entry 1 year post study entry Incidence of a 5% difference in intra-patient BMD scores at baseline Baseline Serum and urine N-telopeptide and serum alkaline phosphatase at baseline and 6 months Up to 6 months Frequency and severity of toxicity as measured by NCI CTC version 2.0 Up to 1 year post study treatment Menopausal symptoms as measured by the Greene Climacteric Scale (GCS) at baseline, monthly during chemotherapy, at 6 months, 1 year, and 2 years after study entry Up to 2 years post study entry Association of baseline serum estradiol levels with permanent cessation of menses Baseline Relationship between the subscales of the GCS (psychological, vasomotor, somatic and sexual) with type of chemotherapy, duration of chemotherapy, and menstrual cycle changes Up to 2 years post study entry
Trial Locations
- Locations (195)
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Aurora Presbyterian Hospital
🇺🇸Aurora, Colorado, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
Scroll for more (185 remaining)Mobile Infirmary Medical Center🇺🇸Mobile, Alabama, United States