Denosumab for the Treatment of Osteoporosis in Children: A Pilot Study

Model scores of the 29,894 trials active now.

Model score 23% for any early termination, 14% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (220 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-02-03. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subjectkgmonthsintravenoushealthy
  Phrases that lowered it: to evaluatesurgeryevaluate theefficacyacid
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 13.6% (raises risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Blinding: single (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: parallel (raises risk) · Design
• Minimum age: 4 (lowers risk) · Who can join
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Responsible party: principal investigator (lowers risk) · Design
• Drug's FAERS reports marked serious: 77.3% (lowers risk) · Drug's FDA history
• Drug's FAERS reports with a death: 20.0% (lowers risk) · Drug's FDA history
• Maximum age: 16 (raises risk) · Who can join
• Drug's FAERS reports in the prior 12 months: 20558 (lowers risk) · Drug's FDA history
• Collaborators: 0 (raises risk) · Design
• Sponsor's past trials: 22 (lowers risk) · Sponsor's track record
• Drug's FAERS reports before start: 71587 (raises risk) · Drug's FDA history
• Disease area, metabolic: Yes (lowers risk) · Disease area

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI NCT02352753 · started 2015 · scored riskier than 70% of active trials terminated
• Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta NCT03638128 · started 2018 · scored riskier than 19% of active trials terminated
• 1 Year Open-label Extension to CZOL446H2337 Safety and Efficacy Trial of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids NCT01197300 · started 2010 · scored riskier than 72% of active trials completed
• Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis NCT03164928 · started 2018 · scored riskier than 58% of active trials completed
• Study of Denosumab for Prevention of Skeletal Disease Progression in Children With Fibrous Dysplasia NCT05419050 · started 2022 · scored riskier than 59% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.