A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (493 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2010-08-31, after 2009-06-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2010-08-31. 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: bonecarcinomatherapybiopsycompleted
Phrases that lowered it: masstopicalparticipantsafetynasal -
Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 6.4% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 65 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: not given (raises risk) · Who can join
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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Primary purpose: supportive care (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, musculoskeletal: Yes (raises risk) · Disease area
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Sponsor's past trials: 156 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Responsible party: sponsor (lowers 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
- supportive care (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 7 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 156 (typical: 32)
- Sponsor's past termination rate
- 6.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 65 (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
- 1 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, 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 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
- Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis NCT00926380 · started 2009 · scored riskier than 62% of active trials completed
- Bisphosphonates for Prevention of Post-Denosumab Bone Loss NCT03396315 · started 2018 · scored riskier than 39% of active trials completed
- Denosumab China Phase III Study NCT02014467 · started 2014 · scored riskier than 19% of active trials completed
- Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis NCT00980174 · started 2009 · scored riskier than 14% 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.