Teriparatide
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Teriparatide: From Osteoporosis to duodenal ulcer (disease)
One-Sentence Summary
Teriparatide is a parathyroid hormone fragment (PTH 1-34) used to treat osteoporosis, including postmenopausal osteoporosis. The TxGNN model ranks duodenal ulcer as its top predicted new indication, but no clinical trials and no publications support this prediction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Postmenopausal osteoporosis; osteoporosis |
| Predicted New Indication | Duodenal ulcer |
| TxGNN Prediction Score | 0.9986 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
The data compiled for this report do not include a curated mechanism-of-action statement. Pharmacology records show that teriparatide acts on the PTH1 receptor (PTH1R) and also binds the PTH2 receptor (PTH2R). Its established clinical role is as a bone-building (anabolic) agent for patients at high risk of fracture.
No plausible link between this bone-anabolic signalling and duodenal ulcer healing was found in the supplied data. The prediction (score 0.9986) comes from the TxGNN model (deep learning) alone. A high score may reflect similarities the model learned between related diseases, not biological evidence, and does not show demonstrated biology or clinical benefit. Without supporting studies, this prediction should be treated as a hypothesis only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 14093R | Terrosa | Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen | Not listed in the data compiled |
Safety Considerations
Product Information (PI) warnings and contraindications were not available in the data compiled. Please refer to the TGA-approved Product Information (PI) for label safety information.
- Disease-level contraindication signals (knowledge graph, not label text): hypercalcaemia, hyperparathyroidism, bone osteosarcoma, bone Paget disease (including juvenile), osteomalacia, rickets, renal osteodystrophy, osteitis fibrosa, nephrocalcinosis, urolithiasis, phosphorus metabolism disease and hypotensive disorder. Verify each against the PI.
- Drug interactions (8 records):
- Moderate: calcitriol (topical), calcipotriol (topical), digoxin and digitoxin.
- Minor: hydrochlorothiazide and furosemide.
- Two further records are receptor-target entries (PTH1R and PTH2R), not drug interactions.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on the model score alone (L5), with no trials, no literature and no plausible mechanism for duodenal ulcer. Evidence is insufficient to justify further investment in this indication.
To proceed, the following is needed:
- A mechanistic rationale linking PTH receptor signalling to duodenal mucosal healing, followed by preclinical data
- Any clinical or observational evidence of teriparatide in peptic or duodenal disease
- Retrieval and review of the TGA-approved PI for warnings and contraindications
- Review of the lower-ranked prediction pregnancy-associated osteoporosis (rank 8). It has L3 evidence from 20 publications, mostly reviews and observational studies, and a “Proceed with Guardrails” assessment. Study designs there were inferred from titles and need verification against the full texts. Use would need to be after lactation has ceased and pregnancy excluded.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.