Continued suppression of bone turnover following a single dose of zoledronic acid: Time to re-think dosing intervals in the management of bone metastases?
Bibliographic record
Abstract
9111 Background: The management of patients (pts) with bone metastases has changed significantly over the past decade, with the advent of newer, more potent anti-osteoclastic agents. However, the dosing interval in which these agents are given has not changed; pts are still dosed at a frequency of monthly or q3weekly injections. It is not known if this is the optimal dosing frequency or due to convention. The purpose of this study was to determine the duration of suppression of bone turnover by Zoledronic Acid (ZA) in a population of bisphosphonate naive metastatic breast cancer (MBC) pts. Methods: This prospective single arm phase II study enrolled 26 pts with MBC to bone who had not received bisphosphonates in the metastatic setting. A single dose of ZA was given at week 0, and biomarkers of bone turnover (serum CTX) were collected every 2 weeks subsequently. Pain scores and quality of life data were collected every 4 weeks. Pts remained on study if their biomarkers remained suppressed, but came off study as soon as escape from suppression was noted, (defined as a rise > 50% of baseline value). Results: At 12 weeks, 73% (95% CI 56%-90%) of pts had continued suppression of bone turnover demonstrated by serum CTX. The pts that escaped suppression did so at a median of 8 weeks after first infusion of ZA (range 8-10 weeks). The magnitude of suppression (proportion decrease from baseline) of serum CTX at week 4 was significantly greater in those who had continued suppression compared to those who escaped suppression before 12 weeks (75% vs 58%, p = 0.02). The absolute baseline value of CTX was significantly lower in pts who maintained suppression (507 vs. 745 ng/L, p = 0.04). Quality of life scores and pain medication use did not change appreciably during this period. Conclusions: This study suggests that ZA may not need to be given at conventional intervals in the majority of pts, and may safely be withheld without increased risk to morbidity or decline in quality of life over a 12 week period. Baseline CTX and the magnitude of suppression of bone turnover at 4 weeks may predict for the optimal dosing frequency. Confirmation in a randomized trial is needed.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".