A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 15% of the time (7,397 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 2015-07-31, after 2014-07-31 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 2015-07-31. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: concurrentpatientdlpatientsfunction
Phrases that lowered it: volunteersefficacyvisitkgoral -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Maximum age: 80 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 9.4% (lowers risk) · Drug's FDA history
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Blinding: none (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
-
Responsible party: sponsor (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Number of arms: 1 (raises risk) · Design
-
Drug's FAERS reports marked serious: 75.2% (lowers risk) · Drug's FDA history
-
Disease area, neurology: No (lowers risk) · Disease area
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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 80 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 39478 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1113 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- endocrine
- Drugs matched to FDA substances
- parathyroid hormone, teriparatide
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 Three Stage, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in Healthy Subjects NCT02202603 · started 2011 · scored riskier than 2% of active trials completed
- A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects NCT02571140 · started 2013 · scored riskier than 1% of active trials completed
- Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism NCT03516773 · started 2018 · scored riskier than 10% of active trials completed
- HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism NCT01199614 · started 2009 · scored riskier than 33% of active trials completed
- Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism NCT03364738 · started 2018 · scored riskier than 75% of active trials terminated
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.