N/A
Completed N=290
Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer
Breast Cancer · Other Disorders of Bone Density and Structure
Source: ClinicalTrials.gov NCT01298362 ↗
Enrolled (actual)
290
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy — -0.72 percentage of change
Summary
The purpose of this study is to identify the combined impact on bone loss as well as the incidence of bone fractures in women with estrogen receptor (ER)-positive, early breast cancer treated with an aromatase inhibitor (AI) either as first line therapy or as maintenance therapy after initial treatment with chemotherapy, in real life clinical settings in Greece.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy |
-0.72 | — |
| SECONDARY Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy. |
0.83 | — |
| SECONDARY Percentage Change in Lumbar Spine Bone Mineral Density Before AI Commencement to Month 12 of Therapy for Patients Who Are Treated With AIs as First Line Therapy |
1.51 | — |
| SECONDARY Percentage Change in Total Hip Bone Mineral Density Before AI Commencement to Month 12 of Therapy for Patients Who Are Treated With AIs as First Line Therapy |
-0.94 | — |
| SECONDARY Bone Fracture Rate |
0; 0 | — |
| SECONDARY Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion |
-0.19 | — |
| SECONDARY Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy. |
-0.59 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent.
- Age ≥ 40 years.
- Female patients with ER-positive early breast cancer, who receive therapy with a third generation AI either as first line hormonal treatment or as maintenance therapy after first-line anthracycline- and/or taxane-based chemotherapy for a period no longer than 1 month (4 weeks) prior to inclusion in the present study.
- Women who have been rendered postmenopausal prior to chemotherapy commencement and at least 12 months from last menstrual period. For subjects who are amenorrheic for = -2 in any site) under treatment with oral or intravenous bisphosphonates. Vitamin D and calcium supplements are allowed.
- Patients with severe osteopenia or osteoporosis (T score <= -2 in any site) under treatment with intravenous bisphosphonates. Oral bisphosphonates, Vitamin D and calcium supplements are allowed.
- Patients under treatment with oral or intravenous bisphosphonates before chemotherapy commencement.
- Patients that stopped hormone-replacement therapy (HRT) less than 3 months before chemotherapy commencement.
- Patients that received neo-adjuvant treatment.
Data sourced from ClinicalTrials.gov (NCT01298362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.