ACTRN12616001051437
Completed
Phase 3
Efficacy study to evaluate denosumab compared to placebo in preventing microstructural bone decay in premenopausal women receiving total oestradiol depletion therapy for early breast cancer
Professor Mathis Grossmann0 sites74 target enrollmentAugust 5, 2016
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- premenopausal osteoporosis
- Sponsor
- Professor Mathis Grossmann
- Enrollment
- 74
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Premenopausal women with oestrogen\-receptor positive, non\-metastatic breast cancer (TxNxM0\) based on documented pathological and radiological evaluation. Menopausal status will be defined clinically at the diagnosis of breast cancer.
- •Premenopausal: a regular cycle in the last 3 months prior to diagnosis of breast cancer
- •Perimenopausal: absent cycles for 3\-12 months
- •Postmenopausal: absent cycles for 12 months or more
- •\-About to commence treatment with ovarian suppression with a view to subsequent aromatase inhibition as determined by the treating oncologist
- •\-Endocrine therapy intended for at least 12 months
- •\-Eastern Cooperative Oncology Group (ECOG) 0 and 1
- •\-Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in the study
- •\-Able and willing to meet all protocol\-required procedures and visits
Exclusion Criteria
- •\-Bone mineral density T\-score at the lumbar spine/hip/femoral neck \<\-2\.0SD
- •\-Pre\-existing minimal trauma fractures (excluding fractures of fingers, toes, hands, feet and skull)
- •Current evidence or prior history of any of the following:
- •\-Metabolic bone disorder(s)
- •\-Drugs for treatment of bone\-related disorders
- •\-Prolonged glucocorticoid use for 2 or more weeks continuously in the past 6 months
- •\-Significant inflammatory or malabsorptive condition(s)
- •\-Osteonecrosis or osteomyelitis of the jaw
- •\-Atypical femoral fracture(s)
- •\-Diabetes mellitus
Outcomes
Primary Outcomes
Not specified
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