A randomised, double-blind, placebo controlled trial to examine the effects of total oestradiol depletion on bone microstructure and the efficacy of denosumab in preventing microstructural bone decay in premenopausal women with early breast cancer

Phase 3

Completed

• Conditions: premenopausal osteoporosis; breast cancer; Metabolic and Endocrine - Other endocrine disorders; Cancer - Breast; Musculoskeletal - Osteoporosis

• Registration Number: ACTRN12616001051437
• Lead Sponsor: Professor Mathis Grossmann

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-05
• Study Completion: 2021-03-15
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 74

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

-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
total volumetric BMD at the distal tibia measured using high-resolution peripheral quantitative computed tomography[12 months from baseline ]