Prospective observational study of denosumab in postmenopausal women over 3 years: a Singapore study.

Objective

This study aimed to evaluate treatment outcomes in postmenopausal women following 3 years of denosumab therapy, primarily assessing bone mineral density (BMD) changes post treatment and secondarily evaluating treatment-related adverse events and complications.

Method

The prospective observational study comprised 318 postmenopausal women (aged 43-90 years) who completed the 3-year denosumab therapy. BMD measurements at the lumbar spine, femoral neck and total hip were assessed. Multivariate analysis was conducted to identify factors influencing BMD response to therapy whilst adverse events were systematically monitored throughout treatment.

Results

Mean age at baseline was 68 years. The mean baseline BMD T-score was -1.9 for lumbar spine, -2.4 for neck of femur (NOF) and -2.1 for total hip. After 3 years of denosumab therapy, mean percentage changes in BMD were 6.95% (standard deviation [SD] 6.48), 3.89% (SD 5.89) and 4.77% (SD 5.46) for the lumbar spine, NOF and total hip, respectively. Lower baseline BMD T-scores were associated with high responder status at all skeletal sites. High body mass index was associated with greater treatment response at NOF and total hip. Prior bisphosphonate treatment was associated with lower responder status at selected skeletal sites. Musculoskeletal pain was the most common adverse event (n = 19, 6%). One case of osteonecrosis of the jaw occurred in a patient with prior alendronate exposure.

Conclusions

This is the first study to evaluate the effectiveness of denosumab among postmenopausal women with osteoporosis in Singapore. Our findings demonstrate that denosumab's ability to enhance BMD is consistent with the efficacy demonstrated in global clinical trials, supporting its use in the local clinical setting.