Randomized controlled trial of pre-transplant zoledronate versus observation for prevention of bone loss in allogeneic hematopoietic cell transplantation
Bibliographic record
Abstract
Background: Approximately half of allogeneic hematopoietic cell transplantation (HCT) recipients experience significant bone loss in the early post-HCT period.Only recently have international guidelines started recommending early screening.However, the guidance for intervention remains conservative.In this study, we sought to evaluate the efficacy of pre-transplant prophylactic zoledronate in preventing early bone loss in allogeneic HCT recipients. Methods:This was an open-label, investigator-initiated, phase 2 randomized controlled trial (RCT) of prophylactic zoledronate versus observation to prevent bone loss in allogeneic HCT recipients.Recipients aged 18 years of age were included after informed consent and randomized to prophylactic zoledronate 4 mg pre-HCT or observation in a 1:1 ratio.The primary outcome of the study was bone mineral density (BMD) loss at the femoral neck (FN), total hip (TH), and lumbar spine (LS), as assessed using dual-energy X-ray absorptiometry (DXA) on day+100 post-HCT.The secondary outcomes included BMD loss on day+365 and Z scores on day+100 and day+ 365 at the FN, TH, and LS sites. Results:The trial was terminated because the interim analysis showed a significant benefit in the intervention arm, with 50% planned recruitment.A total of 40 patients were randomized to the zoledronate and control arms.Both arms were matched for age, sex, diagnosis, pre-HCT steroid exposure, body mass index, human leukocyte antigen (HLA) match, and conditioning intensity.The grade 2-4 acute graft versus host disease (GVHD) incidences were comparable.The primary endpoint of BMD loss at FN and TH at day+100 was significant (5.62% vs. -6.78%,p = 0.009, -1.59 vs. -3.98,p = 0.016, respectively).There was no difference in the secondary endpoint of BMD loss on day+365 compared to that on day+100 or baseline at any BMD site.There was no difference in the Z-scores at any site on day+100 or day+365.Conclusions: Prophylactic zoledronate prevented early bone loss on day+100.The indicated preemptive zoledronate beyond day+100 in recipients prevented further bone loss.Patients receiving prophylactic zoledronate may benefit from a supplementary dose of the indicated preemptive zoledronate.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.000 |
| 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 | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".