Clinical trial · Interventional
Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02
TEXT-Bone: A Substudy of the TEXT Trial to Evaluate Serial Bone Markers for Bone Remodeling, Serial Growth Factors, and Bone Mineral Density
- 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: Gathering information over time from bone density and laboratory tests of women with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study of breast cancer in the future. PURPOSE: This clinical trial is studying changes in bone mineral density in women with breast cancer treated with triptorelin and tamoxifen or exemestane on protocol IBC SG-25-02 (TEXT).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dual x-ray absorptiometry | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Triptorelin plus tamoxifen
- description
- Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years.
- interventionNames
- Other: laboratory biomarker analysis
- Procedure: dual x-ray absorptiometry
- type
- EXPERIMENTAL
- label
- Triptorelin plus exemestane
- description
- Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus exemestane for 5 years.
- interventionNames
- Other: laboratory biomarker analysis
- Procedure: dual x-ray absorptiometry
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Patient must be eligible and enrolled in the TEXT-2 trial prior to enrolling in TEXT-Bone * Serial bone marrow density (BMD) measurements must be taken within the same institution * Hormone receptor positive PATIENT CHARACTERISTICS: * See Disease Characteristics * Premenopausal * No bone fracture in the past 6 months that, in the investigator's judgement, could be related to bone fragility * No clinical or biochemical malabsorption syndrome, known vitamin D deficiency, active hyper- or hypoparathyroidism, or Paget's disease * No uncontrolled thyroid disease, Cushing disease, or other pituitary diseases * No other bone disease (including osteomalacia or osteogenesis imperfecta) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 6 months since prior and no concurrent bisphosphonate therapy (or other bone therapies such as PTH or strontium) * At least 6 months since prior glucocorticoid (\> 5 mg prednisone or equivalent) for \> 1 month * At least 12 months since prior anticonvulsants
References
Publications (0)
Data not yet available