Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (238 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 2022-03-28. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subjectapplysubjectspriorbone
  Phrases that lowered it: productdaytermefficacysafety
• Drug's FAERS reports marked serious: 51.5% (lowers risk) · Drug's FDA history
• Sponsor's past termination rate: 10.2% (raises risk) · Sponsor's track record
• Drug's FAERS reports with a death: 16.4% (lowers risk) · Drug's FDA history
• Design: parallel (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 52 (lowers risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports before start: 118224 (lowers risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 509 (raises risk) · Sponsor's track record
• Disease area, dermatology: Yes (raises risk) · Disease area
• Number of arms: 3 (lowers risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Drug's FAERS reports in the prior 12 months: 50478 (lowers risk) · Drug's FDA history

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.

• 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
• 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 to SRE Studies in United Kingdom and Czech Republic Only NCT00950911 · started 2009 · scored riskier than 7% of active trials completed
• Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant NCT03925532 · started 2019 · scored riskier than 99% 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

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.