Expected change: a new concept for monitoring patients on oral bisphosphonates.
Marian Schini, Margaret A Paggiosi, Fatma Gossiel et al.
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In 30 seconds
This randomized controlled trial evaluated ways to monitor response to oral bisphosphonates in 108 postmenopausal women younger than 85 years treated with alendronate, ibandronate, or risedronate, with calcium and vitamin D, for 2 years. The authors proposed “expected change”: the change exceeded by 90% of adherent patients, assessed at 3 months for bone turnover markers (BTMs) and 24 months for bone mineral density (BMD). CTX and PINP performed better than BMD; their expected changes exceeded the least significant change, whereas those for lumbar spine and total hip BMD did not.
Key findings
- Signal-to-noise ratios were 9.4 for CTX and 10.2 for PINP, compared with 4.1 for lumbar spine BMD and 2.1 for total hip BMD.
- The proportion exceeding the least significant change was 96% for CTX and 94% for PINP, versus 47% for lumbar spine BMD and 24% for total hip BMD.
- Expected changes exceeded the least significant change for CTX (0.233) and PINP (12.1 ng/mL), but not for either BMD measure.
Why it matters
Monitoring can help identify inadequate response or nonadherence to oral bisphosphonate therapy. In this study, blood bone turnover markers distinguished treatment response more consistently than BMD using the proposed expected-change approach. This offers a biologically anchored way to interpret monitoring results, while the findings remain specific to the studied population and treatment setting.
What to keep in mind
The study included postmenopausal women younger than 85 years receiving three oral bisphosphonates; the abstract does not report validation of the expected-change approach in other populations or settings.