Teriparatide Did Not Increase Adult Osteosarcoma Incidence in a 15-Year US Postmarketing Surveillance Study.

Gilsenan A, Midkiff K, Harris D, Kellier-Steele N, McSorley D, Andrews EB

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research13 Oct 2020Cited by 71 (Europe PMC)

PMID32990990PMCIDPMC7988650DOI10.1002/jbmr.4188PepBankPUB-32990990

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Summary

The Osteosarcoma Surveillance Study was initiated in the United States in 2003 to monitor for a potential association between the osteoporosis treatment teriparatide and osteosarcoma. Osteosarcoma occurs at a background incidence rate of approximately 2.5 cases per million per year in US adults aged 40 years or older. For this study, incident cases of osteosarcoma diagnosed between January 1, 2003, and December 31, 2016, were identified through participating cancer registries in the United States. Information on prior exposure to medications and possible risk factors was obtained by self-report (or proxy report) in telephone interviews. Exposure information was verified through medical record abstraction for a sample of patients. A standardized incidence ratio was estimated to compare the observed and expected numbers of osteosarcoma patients with a prior history of teriparatide treatment. Interviews were completed for 24% (1173) of patients diagnosed with osteosarcoma between 2003 and 2016; three reports of teriparatide use before diagnosis were identified. Based on the background incidence rate, the expected number of osteosarcoma cases among patients treated with teriparatide was 4.17. Given the three observed cases, the standardized incidence ratio was 0.72 (90% confidence interval [CI], 0.20 to 1.86). Demographic characteristics were similar for interviewed and noninterviewed patients. Agreement was >90% between self-reported and chart-recorded exposure to osteoporosis medications. Mean age of interviewed patients was 61 years; 53% of patients were male, 84% were white, and 5% were Hispanic. The prevalence of suspected risk factors for development of osteosarcoma among the osteosarcoma cohort was 19% for history of radiation and 4% for history of Paget's disease of bone. These findings showed that the incidence of osteosarcoma associated with teriparatide use during the 15-year surveillance period was no different than would be expected based on the background incidence rate of osteosarcoma. © 2020 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

01HumanObservational studySafety outcome
In US osteosarcoma surveillance, three interviewed patients reported teriparatide use before diagnosis.
In plain wordsIn US surveillance, three patients with osteosarcoma reported prior teriparatide use. This does not establish that teriparatide caused cancer.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedOsteosarcoma cases with prior teriparatide exposure
Study
n = 1,173
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated
Measurements
prior teriparatide exposure reports
3 cases
interviewed osteosarcoma patients
Source sentences
Summary
Interviews were completed for 24% (1173) of patients diagnosed with osteosarcoma between 2003 and 2016; three reports of teriparatide use before diagnosis were identified.
2 context sentences(design, population, supporting numbers)
Summary · context
For this study, incident cases of osteosarcoma diagnosed between January 1, 2003, and December 31, 2016, were identified through participating cancer registries in the United States.
Summary · context
Information on prior exposure to medications and possible risk factors was obtained by self-report (or proxy report) in telephone interviews.
Show in the study text Report a problemFND-3299099001
02HumanObservational studySafety outcome
In US surveillance, prior teriparatide use was linked to an osteosarcoma incidence ratio consistent with expected background incidence.
In plain wordsIn US surveillance, teriparatide use was linked to osteosarcoma incidence consistent with the expected background rate.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeStandardized osteosarcoma incidence ratio
Study
n = 1,173
Comparator
expected background osteosarcoma incidence
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated
Measurements
standardized incidence ratio
0.72 ratio
three observed cases
90% CI lower
0.2 ratio
standardized incidence ratio
90% CI upper
1.86 ratio
standardized incidence ratio
expected cases
4.17 cases
teriparatide-treated patients
Source sentences
Summary
Given the three observed cases, the standardized incidence ratio was 0.72 (90% confidence interval [CI], 0.20 to 1.86).
4 context sentences(design, population, supporting numbers)
Summary · context
Based on the background incidence rate, the expected number of osteosarcoma cases among patients treated with teriparatide was 4.17.
Summary · context
These findings showed that the incidence of osteosarcoma associated with teriparatide use during the 15-year surveillance period was no different than would be expected based on the background incidence rate of osteosarcoma. © 2020 The Authors.
Summary · context
For this study, incident cases of osteosarcoma diagnosed between January 1, 2003, and December 31, 2016, were identified through participating cancer registries in the United States.
Summary · context
Information on prior exposure to medications and possible risk factors was obtained by self-report (or proxy report) in telephone interviews.
Show in the study text Report a problemFND-3299099002

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Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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