Teriparatide official document review · version 1
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Inside the official reviews
Reviewed 2026-09-19 · Preserved version 1
Fracture outcomes differ from bone-density outcomes
EMA’s initial Forsteo discussion reports fewer new vertebral and non-vertebral fractures in postmenopausal women, but inconclusive results for individual sites such as the hip. Increased bone mineral density is a different endpoint. EMA PDF pp. 21 ↗
More findings, study links and document coverage
Both pivotal trials ended early
The assessment describes early termination of the pivotal trials and median treatment durations of 19 months in women and 11 months in men. These limits matter when interpreting persistence and uncommon adverse effects. EMA PDF pp. 21 ↗
The original male indication was disputed
In this initial assessment, the committee did not accept extrapolating fracture reduction in women to men solely from bone-density results. The original recommendation covered postmenopausal women; later indication extensions require separate review. EMA PDF pp. 21, 22 ↗
Animal findings prompted further surveillance
The review discusses rat osteosarcoma findings and the limits of the then-available human follow-up. It did not establish an observed human cancer risk; this historical concern must be distinguished from later surveillance and current labeling. EMA PDF pp. 20, 21 ↗
Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.
Document coverage
Selected sections read in 1 of 1 inventoried documents; 0 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.
One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading. EMA inventory source ↗
Inspect documents, application identities and source pins
Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.
Forsteo : EPAR - Scientific Discussion ↗
Selected sections reviewed · ema-27569 · Document/feed date: 2005-10-21
The undated initial scientific discussion names the product. Application identity comes from the separately pinned EMA medicine record, and the date is the documents-feed first-publication date, not an adoption date.
Verified: Forsteo · EMEA/H/C/000425 · EMA first-publication date 2005-10-21. Product identity checked on PDF pp. 1.
The undated PDF does not print the application number. The application is reconciled separately against EMA medicine record EMEA/H/C/000425 ↗, retrieved 2026-09-15. Its first-publication date is not an assessment-adoption date.
Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal.
Retrieved 2026-09-19. Read PDF pages: 1, 20, 21, 22 of 22. SHA-256:
c0c59f61296f01a3e99817d905b3b96e724f35979e31ab741bab66889db9dec5.Feed-listed application (not a verified association): EMEA/H/C/000425.
Remaining work
- Review subsequent male and glucocorticoid-induced osteoporosis assessments and current labels.
- Reconcile long-term human osteosarcoma surveillance and post-treatment fracture follow-up with this historical assessment.