Clinical trial · Observational
An Open Label Non-Interventional Evaluation of the Effect of Adjuvant Hormonal Treatment of Postmenopausal Women Wih Early Breast Cancer With Aromatase Inhibitors on Bone Mineral Density and Bone Fracture Rate in Daily Practice
NCT00767585CI-TRIAL-00002427completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this study is to determine the effect of aromatase inhibitors therapy on bone mineral density and compare it to the effects of tamoxifen and no hormonal therapy.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (8)
- label
- A:
- description
- 70 women with hormone-dependent or hormone-independent early breast cancer that have completed their chemo- and/or radiotherapy just recently (up to 6 months after completion of therapy)
- label
- B
- description
- 70 women with hormone-independent early breast cancer, 24-36 months after completion of chemo- and/or radiotherapy
- label
- C
- description
- 70 women with hormone-independent early breast cancer, 54-66 months after completion of chemo- and/or radiotherapy
- label
- D
- description
- 70 women with hormone-dependent early breast cancer, 24-36 months after initiation of tamoxifen therapy
- label
- E
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 55-65 years, diagnosed with invasive early breast cancer: - Surgery, chemo- and/or radiotherapy concluded less than 6 months ago * Women with hormone-independent breast cancer: - Surgery, chemo- and/or radiotherapy concluded before 24-36 months or 54-66 months * Women with hormone-dependent breast cancer:- Adjuvant therapy with tamoxifen initiated before 24-36 and 54-66 months or - Adjuvant therapy with aromatase inhibitor initiated before 24-36 and 54-66 months or - Switch from tamoxifen to aromatase inhibitor initiated before 24-36 months Exclusion Criteria: * Women receiving active treatment for osteoporosis * Women with any evidence of breast cancer recurrence
References
Publications (0)
Data not yet available
No reference posted for this study.