Clinical trial · Interventional
Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98
Investigating Bone Density and Bone Loss Without Baseline Information
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 treatment. PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dual energy X-ray absorptiometry (DEXA) | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| Spine X-ray | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Tamoxifen for 5 years
- description
- Patients treated with tamoxifen for 5 years after randomisation.
- interventionNames
- Other: laboratory biomarker analysis
- Procedure: Dual energy X-ray absorptiometry (DEXA)
- Procedure: Spine X-ray
- type
- EXPERIMENTAL
- label
- Letrozole for 5 years
- description
- Patients treated with letrozole for 5 years after randomisation.
- interventionNames
- Other: laboratory biomarker analysis
- Procedure: Dual energy X-ray absorptiometry (DEXA)
- Procedure: Spine X-ray
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
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 weeksReferences
Publications (1)
- DERIVEDDecensi A, Sun Z, Guerrieri-Gonzaga A, Thurlimann B, McIntosh C, Tondini C, Monnier A, Campone M, Debled M, Schonenberger A, Zaman K, Johansson H, Price KN, Gelber RD, Goldhirsch A, Coates AS, Aebi S. Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences. Breast Cancer Res Treat. 2014 Apr;144(2):321-9. doi: 10.1007/s10549-014-2849-2. Epub 2014 Feb 1. PMID 24487691