Status:
COMPLETED
Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98
Lead Sponsor:
ETOP IBCSG Partners Foundation
Conditions:
Breast Cancer
Osteoporosis
Eligibility:
FEMALE
30+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better t...
Detailed Description
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 recei...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT00369850
Start Date
May 1 2004
End Date
January 1 2012
Last Update
July 27 2012
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
2
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
3
Institut Bergonie
Bordeaux, France, 33076
4
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081