Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents
Model scores of the 29,894 trials active now.
Model score 8% 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 6% of the time (122 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 2017-01-31, after 2009-11-30 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 2017-01-31. 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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Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 3.8% (lowers 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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Trials the sponsor started in the prior 2 years: 90 (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: bonetherapypriorgrowthentry
Phrases that lowered it: participantshiv infectedantiretroviralin hivweight -
Sponsor's past trials: 765 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 10.1% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 24 (raises risk) · Who can join
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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports in the prior 12 months: 10124 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 75.0% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 11 (typical: 18)
- Maximum age
- 24 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 765 (typical: 32)
- Sponsor's past termination rate
- 3.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 90 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 51908 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 10124 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, immunology, urogenital
- Drugs matched to FDA substances
- alendronate, carbonate, 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
- Multicentre Study To Assess Changes In Bone Mineral Density Of The Switch From Tenofovir To Abacavir In Hiv-1-Infected Subjects With Loss Of Bone Mineral Density NCT01153217 · started 2010 · scored riskier than 12% of active trials completed
- Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial NCT01968850 · started 2014 · scored riskier than 18% of active trials completed
- High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART NCT01403051 · started 2011 · scored riskier than 75% of active trials completed
- Multicentre Study To Assess Changes In Bone Mineral Density Of The Switch From Protease Inhibitors To Dolutegravir In HIV-1-Infected Subjects With Low Bone Mineral Density NCT01966822 · started 2014 · scored riskier than 20% of active trials completed
- Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV) NCT01228318 · started 2011 · scored riskier than 39% 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.