Clinical trial
Prevention of Osteoporosis in Breast Cancer Survivors
Name
0536-01-FB
Description
The purpose of this study is to test whether strength/weight training exercises enhance the effectiveness of calcium, vitamin D, and risedronate for the prevention and treatment of osteoporosis in postmenopausal breast cancer survivors.
Trial arms
Trial start
2002-04-01
Estimated PCD
2007-12-01
Trial end
2007-12-01
Status
Completed
Treatment
Strength/Weight Training & Drug/Supplement
G1 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week and strength/weight training exercises for upper and lower extremities and the spine.
Arms:
Strength/Weight Training
Other names:
Actonel
Drug/Supplement only
G2 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week, but do not participate in strength/weight training exercises.
Arms:
Drug Supplement only
Other names:
Actonel
Size
249
Primary endpoint
Bone Mineral Density
at 12, 24, and 36 months
Eligibility criteria
Inclusion Criteria:
* read, speak and understand English;
* be female;
* be between the ages of 35 and 75;
* have completed treatment (except tamoxifen) for stage 0, I or II breast cancer (i.e. surgery, chemotherapy, radiation) at least 6 months prior to admission to the study;
* be 1 year postmenopausal (12-months amenorrheic; subjects 55-years or younger with history of hysterectomy without oophorectomy must have it confirmed by two baseline measures of FSH \>40 IU/ml);
* have a BMD T-score of -1.0 SD or lower at one or more sites (spine, hip or forearm); and
* have agreement of their primary care provider for participation in the study.
Exclusion Criteria:
* have a recurrence of their breast cancer;
* currently take hormone replacement therapy, bisphosphonates, calcitonin, raloxifene, calcitriol, or glucocorticosteroids.;
* currently do strength/weight training exercises or high impact exercises (such as running, jumping rope, high impact aerobic dance, martial arts, volleyball, or basketball) two to three times weekly;
* have a body mass index (BMI) equal to or greater than 35;
* have serum calcium, creatinine or TSH (if on thyroid therapy) outside the normal limits;
* have active gastrointestinal problems such as dysphagia, esophageal disease, gastritis, duodenitis, or ulcers;
* have Paget=s disease;
* have renal disease (renal stones or serum creatinine levels greater than the upper normal limits);
* have a recent history of a spinal fracture (within the past 6 months);
* have features of an acute fracture on baseline spinal x-rays;
* have other concomitant conditions that prohibit strength/weight training exercises, calcium, or vitamin D intake.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 249, 'type': 'ACTUAL'}}
Updated at
2023-11-30
1 organization
1 product
1 indication
Organization
University of NebraskaProduct
DrugIndication
Osteoporosis