Background Denosumab is a fully human monoclonal antibody that inhibits osteoclast activity, reducing bone loss. In the UK, use of denosumab was approved by National Institute for Health and Clinical Excellence (NICE) from October 2010 (TA204) . Denosumab was used in Rheumatology Department, Queen Elizabeth Hospital, London from October 2010.
Objectives We audited the indications for use of denosumab in these patients. Drug compliance, adverse effect and tolerability of the drug were also analysed.
Methods 81 patients (female 77, male 4, age range 52 to 92 years, mean age 72 years) who commenced denosumab between October 2010 and December 2011 were identified retrospectively. 97% (79/81) of the patients come from their own home and 3% (2/81) come from nursing home. Patients’ demographics, risk factors, fracture history, bone mineral density (BMD), spine and hip T score and previous osteoporosis treatment were assessed. 58 patients had follow up data and renal function was monitored every six months. Side effects were documented.
Results Pre-treatment Dual-emission X-ray Absorptiometry (DXA) was available on all patients (mean BMD spine and hip 0.686 gm/cm2 and 0.705 gm/cm2, mean T score spine and hip -3.025 and -1.776). 87% (75/81) had failed treatment with both oral and intravenous bisphosphonates. 11% (9/81) had breast cancer and were on aromatase inhibitors. 16% (13/81) had mild renal impairment and 7% (6/81) had moderate renal impairment at the base line. 35.8% (29/81) of patients were found to have vitamin D deficiency at baseline and were treated. 9% (7/81) were on denosumab treatment for primary prevention of osteoporosis (T score range -2.3 to -4.1). All of these had failed oral medication previously. Four patients swapped from intravenous Ibandronate due to poor venous access. Use of denosumab was indicated clinically despite lack of specific risk factors suggested by NICE. All patients treated with denosumab for secondary prevention of osteoporosis (91%,74/81) met NICE criteria by virtue of previous fracture and failure of other treatments. Four men were treated off-license. 44% (36/81) had completed six month treatment and 27% (22/81) had completed one year treatment. All these patients were compliant to the drug.
Conclusions Denosumab seems well tolerated and no serious side effect has been observed. Patients’ renal function appears stable on treatment. Patients’ compliance with denosumab is good.
Disclosure of Interest None Declared
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