Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption
Model scores of the 29,894 trials active now.
Model score 26% 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 26% of the time (851 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
Terminated on 2011-04-30, after 2009-04-30 start.
Reason given by the sponsor: “enrollment”
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 2011-04-30. 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: breast cancerchemotherapytherapyboneprimary
Phrases that lowered it: participantsand safetyefficacy andevaluatestudy will -
Phase: 1/2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
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Responsible party: sponsor investigator (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 6.3% (lowers risk) · Drug's FDA history
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Maximum age: 85 (lowers risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
-
Number of arms: 1 (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 75.1% (lowers risk) · Drug's FDA history
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Disease area, dermatology: Yes (raises risk) · Disease area
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Sponsor's past trials: 0 (raises risk) · Sponsor's track record
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Disease area, musculoskeletal: Yes (raises risk) · Disease area
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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
- 1/2 (typical: 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
- sponsor investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 85 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 457 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 153 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology, musculoskeletal
- Drugs matched to FDA substances
- vitamin d
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
- Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D) NCT02186015 · started 2015 · scored riskier than 92% of active trials completed
- Effects of High Dose Calcitriol in Breast Cancer Patients NCT01293682 · started 2010 · scored riskier than 96% of active trials completed
- High Dose Vitamin D vs Standard Dose Vitamin D Study NCT01988090 · started 2013 · scored riskier than 99% of active trials terminated
- Vitamin D in Postmenopausal Women at High Risk for Breast Cancer NCT00859651 · started 2009 · scored riskier than 66% of active trials completed
- Development of Vitamin D as a Therapy for Breast Cancer - Phase 2 NCT00656019 · started 2008 · scored riskier than 96% 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.