Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (607 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-03-11, after 2018-03-05 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-03-11. 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.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patientneckbonechemotherapypatients
Phrases that lowered it: maleosteoarthritisfemalecriteriastudy -
Sponsor's past termination rate: 17.0% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 57.2% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 150 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 18.2% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 97884 (lowers risk) · Drug's FDA history
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Collaborators: 2 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Blinding: double (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
-
Sponsor's past trials: 642 (raises risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 35071 (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.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 642 (typical: 32)
- Sponsor's past termination rate
- 17.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 150 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 97884 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 35071 (typical: 412.5)
- Drug's FAERS reports marked serious
- 57.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, metabolic, immunology, musculoskeletal
- Drugs matched to FDA substances
- denosumab
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab NCT00887965 · started 2009 · scored riskier than 58% of active trials completed
- Denosumab China Phase III Study NCT02014467 · started 2014 · scored riskier than 19% of active trials completed
- Denosumab for the Treatment of Adult LCH NCT03270020 · started 2017 · scored riskier than 77% 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
- Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma NCT01345019 · started 2012 · scored riskier than 53% 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.