Romosozumab in Women With Chronic SCI
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (453 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-06-10, after 2021-03-01 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 2024-06-10. 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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Sponsor's past termination rate: 19.9% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Sponsor's past trials: 548 (raises risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: injuryspinalcordsubjectmonths
Phrases that lowered it: participantsparticipantdiseaseshealthinhaled -
Trials the sponsor started in the prior 2 years: 93 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: single group (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 7.6% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 77.7% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Responsible party: principal investigator (lowers risk) · Design
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Collaborators: 1 (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.
The trial
Design
- Phase
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 13 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 548 (typical: 32)
- Sponsor's past termination rate
- 19.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 93 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 79332 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6729 (typical: 412.5)
- Drug's FAERS reports marked serious
- 77.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, metabolic, musculoskeletal
- Drugs matched to FDA substances
- alendronate, romosozumab
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
- Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI NCT04232657 · started 2021 · scored riskier than 34% of active trials completed
- Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa NCT04779216 · started 2021 · scored riskier than 28% of active trials completed
- A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis NCT03432533 · started 2018 · scored riskier than 33% of active trials completed
- A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis NCT05067335 · started 2021 · scored riskier than 72% of active trials completed
- A Study to Evaluate the Effect of Romosozumab (AMG 785) on Bone Quality of the Forearm in Postmenopausal Women With Low Bone Mass NCT00950950 · started 2009 · scored riskier than 5% 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.