A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture

Model scores of the 29,894 trials active now.

Model score 9% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (1,463 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 2024-07-03. 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) (lowers risk) · Wording Phrases that raised it: randomizationprior tomonths priorsubjects withimaging
  Phrases that lowered it: drugsdiseasesdisorderstypealcohol
• Accepts healthy volunteers: No (raises risk) · Who can join
• Drug's FAERS reports marked serious: 52.9% (lowers risk) · Drug's FDA history
• Phase: 3 (lowers risk) · Design
• Sponsor's past termination rate: 6.7% (lowers risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 13.4% (lowers risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 25 (lowers risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Blinding: quadruple (lowers risk) · Design
• Minimum age: 60 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Maximum age: 90 (lowers risk) · Who can join
• Sponsor's past trials: 15 (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Responsible party: sponsor (lowers risk) · Design
• Number of arms: 2 (raises risk) · Design

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.

• A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis NCT04934072 · started 2021 · scored riskier than 15% of active trials completed
• Denosumab China Phase III Study NCT02014467 · started 2014 · scored riskier than 19% of active trials completed
• A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates NCT00936897 · started 2009 · scored riskier than 40% of active trials completed
• A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass NCT04003467 · started 2019 · scored riskier than 19% of active trials completed
• A Phase 3 Study to Compare Biosimilar Denosumab With Prolia® NCT05405725 · started 2022 · scored riskier than 23% 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.