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 个研究点目标入组 74 人开始时间: 2016年8月5日最近更新: 2022年8月9日

研究概览

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•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

•-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
•-History of any solid organ or bone marrow transplant
•-Malignancy within the last 5 years (except breast cancer and non-melanoma skin cancers)
•Abnormalities of the following per central laboratory reference ranges:
•-Hypo/hypercalcaemia
•-Hypo/hyperparathyroidism
•-Renal impairment (eGFR <45ml/min/1.73m2)
•-25-hydroxy vitamin D deficiency (<12nmol/L). Repletion will be allowed and participants may be re-screened.
•-Self-reported recreational drug use or alcohol dependence within 12 months prior to screening
•-Pregnancy
•-History or evidence of any other clinically significant disorder, condition or disease that in the opinion of the study investigator would pose a risk to participant safety or interfere with the study evaluation, procedures or completion

发起方

Professor Mathis Grossmann