Investigating Bone Density and Bone Loss Without Baseline Information
30 Years
N/A
Female
Breast Cancer, Osteoporosis
Trial Information
Investigating Bone Density and Bone Loss Without Baseline Information
OBJECTIVES:
- Compare the effects on bone mineral density (BMD) in the L2-L4 (posterio-anterior)
region of the spine and hip by assessing bone density in postmenopausal women with
breast cancer receiving treatment on protocol IBCSG-1-98.
- Compare the incidence of radiological gross changes and fractures identified from spine
x-rays (T4-L4) in these patients (in groups 1 and 2).
- Use longitudinal BMD measurements to estimate a linear rate of bone loss based on mixed
effect models.
- Identify serum markers for bone loss to determine how they correlate with osteoporosis,
microfractures, clinical fractures, and breast cancer-related bone events.
OUTLINE: This is a multicenter study and a substudy of protocol IBCSG-1-98. Patients are
assigned to 1 of 3 groups according to the length of treatment they have undergone on
protocol IBCSG-1-98.
- Group 1 (prior to or at the end of the second year of treatment on protocol
IBCSG-1-98): Patients undergo bone mineral density (BMD) testing of the L2-L4 spine and
hip at baseline and years 1, 2, 3, and 4 from baseline. They also undergo x-rays of the
T4-L4 spine at baseline and years 1, 3, and 4 from baseline.
- Group 2 (after 2 years but before the end of the third year of treatment on protocol
IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and
years 1, 2, and 3 from baseline. They also undergo x-rays of the T4-L4 spine at
baseline and years 2 and 3 from baseline.
- Group 3 (after 3 years but before the end of the fifth year of treatment on protocol
IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and
years 1 and 2 from baseline (for patients in 4th year of treatment) or year 1 from
baseline (for patients in 5th year of treatment).
Patients undergo blood collection at baseline and periodically during study for biomarker
correlative study.
PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Resected disease
- Enrolled on protocol IBCSG-1-98
- Receiving adjuvant endocrine therapy comprising 1 of the following regimens:
- Letrozole
- Tamoxifen
- Letrozole after 2 years of tamoxifen
- Tamoxifen after 2 years of letrozole
- Not yet completed 5 years of treatment
- No breast cancer recurrence or second primary cancer
- No known, symptomatic bone disease, including osteomalacia or osteogenesis imperfecta
- No prior registration to protocol IBCSG-1-98 Bone Mineral Density substudy
- Hormone receptor status:
- Estrogen receptor-positive and/or progesterone receptor-positive tumor
PATIENT CHARACTERISTICS:
- Female
- Postmenopausal
- No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary
diseases
- No malabsorption syndrome or clinically relevant vitamin D deficiency
- No patients for whom the bone density determination is impossible
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 1 year since prior and no concurrent anticonvulsants
- More than 6 weeks since prior and no concurrent corticosteroids (at doses > the
equivalent of 5 mg/day prednisone) for > 2 weeks total
- No prior or concurrent sodium fluoride (at daily doses ≥ 5 mg/day) for > 1 month
- More than 12 months since prior and no concurrent anabolic steroids
- More than 6 months since prior treatment, either investigational or not, for the
prevention of osteoporosis (excluding calcium or cholecalciferol [vitamin D])
- No concurrent raloxifene
- Concurrent therapeutic intervention for osteoporosis comprising bisphosphonates
allowed
- Concurrent warfarin allowed provided it is given for ≤ 4 weeks
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Relative percent change of bone mineral density (BMD) form baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98
Outcome Time Frame:
5 years after randomisation to BIG 1-98
Safety Issue:
No
Principal Investigator
Stefan Aebi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Inselspital, Berne
Authority:
United States: Federal Government
Study ID:
CDR0000482381
NCT ID:
NCT00369850
Start Date:
May 2004
Completion Date:
January 2012
Related Keywords:
- Breast Cancer
- Osteoporosis
- osteoporosis
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- Breast Neoplasms
- Osteoporosis
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