Parathyroid Hormone

證據等級: L5 預測適應症: 10

目錄

  1. Parathyroid Hormone
  2. Parathyroid Hormone: From No Approved Indication to Migraine Disorder
    1. One-Sentence Summary
    2. Quick Overview
    3. Why is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. US Market Information
    7. Safety Considerations
    8. Conclusion and Next Steps
    9. Disclaimer

## 藥師評估報告

Parathyroid Hormone: From No Approved Indication to Migraine Disorder

One-Sentence Summary

Parathyroid hormone (PTH, DrugBank DB05829) has no recorded approved indication in this evidence pack and is currently not marketed (0 licenses on file). The TxGNN model’s top prediction suggests possible relevance to Migraine Disorder, but this is supported by only 1 clinical trial (unrelated to PTH pharmacology) and 6 publications, none of which are direct interventional studies of PTH for migraine treatment.


Quick Overview

Item Content
Original Indication Not available — no approved indication on file (drug is not marketed)
Predicted New Indication Migraine Disorder
TxGNN Prediction Score 99.98%
Evidence Level L4 (mechanistic/genetic association only, no interventional evidence)
US Market Status ✗ Not Marketed
Number of NDAs 0
Recommended Decision Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action (MOA) data for parathyroid hormone is not available in this evidence pack, and no approved indication or marketing record exists (market status: not marketed, 0 NDAs). Parathyroid hormone is an endogenous polypeptide hormone that regulates calcium and phosphate homeostasis primarily through effects on bone, kidney, and (indirectly, via vitamin D activation) the intestine.

The TxGNN prediction linking PTH to migraine disorder is based mainly on a 2025 genetic/mechanistic study identifying PTHrP (parathyroid hormone-related peptide) receptor variants as candidate genetic drivers of migraine susceptibility, together with an old (1986) study describing central nervous system effects of calcitonin/parathormone. These are association- or hypothesis-generating findings, not evidence that administering PTH produces a therapeutic effect in migraine patients.

Importantly, the single registered clinical trial captured for this indication (foot reflexology massage for migraine) has no pharmacological relationship to PTH — it appears to have been matched purely on the shared disease label and should not be treated as supporting clinical evidence. Several of the retrieved publications also concern co-interventions (vitamin D, magnesium, amitriptyline) or comorbid conditions (multiple sclerosis/osteoporosis) rather than PTH treatment itself. Taken together, the underlying mechanistic hypothesis is plausible enough to warrant further research, but there is currently no direct interventional evidence supporting PTH as a migraine treatment.


Clinical Trial Evidence

Trial Number Phase Status Enrollment Key Findings
NCT07028684 N/A Completed 22 Studies foot reflexology massage (not PTH) for pain, sleep, and quality of life in women with migraine. Captured only through disease-label matching; not relevant to PTH pharmacology and should not be counted as supporting clinical evidence.

Literature Evidence

PMID Year Type Journal Key Findings
40297711 2025 Review/Genetic Brain Communications Identifies PTHrP receptor variants as candidate genetic drivers of migraine susceptibility; genetic-association evidence, not a treatment study.
3739765 1986 Mechanistic (old) Acta Neurologica Early study on central effects of calcitonin and parathormone; dated, mechanistic only.
24714817 2014 RCT Braz J Med Biol Res Tests vitamin D + amitriptyline (not PTH) for pediatric migraine attack frequency.
31261815 2019 Cohort Medicina (Kaunas) Evaluates vitamin D levels/therapy (not PTH) in childhood migraine.
29429076 2018 Review Neuromolecular Medicine Reviews cardiovascular autonomic dysfunction linking MS, osteoporosis, and neurodegeneration; migraine relevance is indirect.
11425281 2001 Review Medical Hypotheses General review of magnesium deficiency pathology; not specific to PTH or migraine treatment.

US Market Information

No US marketing authorizations are on file for parathyroid hormone in this evidence pack (0 licenses recorded, market status: not marketed).


Safety Considerations

Please refer to the package insert for safety information. No key warnings, contraindications, or drug-drug interaction data were available in this evidence pack (DDI query status: not found).


Conclusion and Next Steps

Decision: Hold

Rationale: The evidence base for PTH in migraine disorder consists only of genetic-association and mechanistic-level findings (L4), with no direct interventional trial testing PTH for migraine — the sole clinical trial retrieved is a reflexology-massage study unrelated to PTH pharmacology. Critical foundational data (MOA, safety warnings/contraindications) are also flagged as blocking data gaps (DG001, DG002), preventing even an initial safety assessment.

To proceed, the following is needed:

  • MOA data for parathyroid hormone (DrugBank API query — DG002)
  • Safety warnings/contraindications from an approved product label (DG001, currently blocking)
  • A direct pharmacological or preclinical study testing PTH (or PTH-pathway modulation) specifically in a migraine model, to move beyond genetic-association evidence
  • Re-verification that future clinical trial matches are filtered for drug-relevance, not disease-label co-occurrence alone

    Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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