NCT00963417Completed
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 · Last updated 14 Jul 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 119 (actual)
- First submitted
- 20 Aug 2009
- Start date
- 3 Aug 2009
- Primary completion date
- 11 Mar 2011
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Diseases
- Osteoporosis
- NCT number
- NCT00963417
What you commit to
- Study type: Interventional
- Participants enrolled: 119
- From 3 Aug 2009 to the primary completion date, 11 Mar 2011
- 13 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to 120 years · Sex: Female · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Brisbane and Women's Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Peter MacCallum Cancer Center Coordinator of this site? Confirm its status | East Melbourne | Australia | Unknown status |
| Maroondah Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Box Hill Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Royal Perth Hospital Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Centre Hospitalier Regional de Huy Coordinator of this site? Confirm its status | Huy | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| CHR Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| C.H.U. Sart-Tilman Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| C.H.P.L.T. de Verviers Coordinator of this site? Confirm its status | Verviers | Belgium | Unknown status |
| Oncology Institute of Southern Switzerland Coordinator of this site? Confirm its status | Bellinzona | Switzerland | Unknown status |
| Inselspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.