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The primary purpose of this study is to compare the efficacy of denosumab treatment with placebo in preventing bone decay in premenopausal women being treated with ovarian suppression and aromatase inhibition for breast cancer.
Who is it for?
You may be eligible to enrol in this trial if you are a premenopausal woman aged 18 to 55 who has been diagnosed with oestrogen-receptor positive, non-metastatic breast cancer (TxNxM0) for which you are scheduled to begin ovarian suppression and aromatase inhibition therapy which is intended to last for at least 12 months.
All participants enrolled in this trial will be randomly allocated (by chance) to receive either denosumab once every six months by subcutaneous injection or to receive placebo once every 6 months for a 12-month study period.
Participants will be followed-up at six and 12 months after starting the trial drug/placebo with scans, blood tests and questionnaires which will be used to measure bone density and structure, body composition, blood markers of bone health and cardiovascular risk and quality of life.
It is hoped that the findings from this trial will provide information on the extent of bone decay which occurs as a result of ovarian suppression and aromatase inhibition therapy, and the efficacy of denosumab in preventing this decay in premenopausal women with oestrogen-receptor positive breast cancer.
Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at email@example.com
Are we out of date? If you have updated or new information about a trial, we’d be grateful if you’d share it with us – email your update to firstname.lastname@example.org