. 2022 Aug 14;6(9):e10665. doi: 10.1002/jbm4.10665

Table 1.

Overview of Study Design and Results of Postmarketing Studies for Teriparatide

	Osteosarcoma Surveillance Study⁽ ⁷ ⁾	European Osteosarcoma Surveillance Study⁽ ³⁶ ⁾	Forteo Patient Registry⁽ ³⁷ ⁾	Forteo Medicare Linkage Study⁽ ³⁸ ⁾	Forteo Commercial Claims Linkage Study
Study design	Case series	Case series	Voluntary prospective cohort	Population‐based comparative cohort	Population‐based comparative cohort
Study location	USA	5 Nordic countries (Denmark, Finland, Iceland, Norway, Sweden)	USA	USA	USA
Outcome data source	Cancer registries ^a	Cancer registries	Cancer registries ^a	Cancer registries	Cancer registries
Exposure data source	Patient self‐report	Chart review	Patient self‐report	Medicare Part D prescription data	Commercial pharmacy claims data
Diagnosis years included	2003–2016	2004–2011	2009–2019	2007–2014	2005–2014
Ages included	≥40 years	≥40 years	≥18 years	≥65 years	≥18 years
Cancer Registry participation	30 cancer registries	Scandinavian Sarcoma Group (SSG) Registry and the Finnish and Swedish National Cancer Registries	42 cancer registries	26 cancer registries	29 cancer registries
No. of patients	1173 interviewed	109	6180 OS cases linked with 75,247 enrolled patients in Forteo Patient Registry	811 OS pts linked to 153,316 teriparatide and 613,247 comparators	4242 OS patients linked to: (1) 335,191 teriparatide and 637,387 osteoporosis and (2) 379,283 teriparatide and 1,428,943 general population
Results	3 patients with confirmed exposure to teriparatide before OS diagnosis	0 OS cases had a record of teriparatide use	0 teripartide users were found to have osteosarcoma	0 matches in teriparatide cohort; <11 matches in comparator cohort ^b	(1) Osteoporosis cohort: 3 matches in teriparatide and 6 in osteoporosis (2) General population cohort: 3 matches (same as in osteoporosis cohort) in teriparatide and 9 in general population
Statistical findings	SIR ^c : 0.72 (90% CI, 0.20–1.86)	IRR 0 (90% CI, 0‐27) ^d	Crude incidence rate: 0.0 (95% CI, 0.0–10.2) cases per million person‐years ^d	IRR: 0.0 (95% CI, 0.0–3.2) ^d	Osteoporosis IRR: 1.0 (95% CI, 0.2–4.5) general population IRR: 1.3 (95% CI, 0.2–5.1) ^e

CI = confidence interval; IRR = incident rate ratio; OS = osteosarcoma; SEER = Surveillance, Epidemiology, and End Results Program; SIR = standardized incidence ratio.

^{^a}

Responses were validated by medical record review in a random sample with >85% agreement.

^{^b}

The study comparator cohort included fewer than 11 observed cases. As a condition of the Medicare data use agreement, to protect patient privacy, nonzero cell counts less than 11 cannot be disclosed; thus, the exact number of cases cannot be reported because it is more than 0 but less than 11.

^{^c}

A background incidence rate of osteosarcoma of 3.2 cases per million per year was age‐ and sex‐adjusted to the teriparatide‐treated population and study interview rate was estimated. Based on these parameters, the expected number of cases of osteosarcoma with teriparatide exposure was 4.17; with three observed cases, the SIR was 0.72 (90% CI, 0.20–1.86).⁽ ⁷ ⁾

^{^d}

Because these studies showed no cases of osteosarcoma with teriparatide exposure, the incidence rate ratio was 0.

^{^e}

Because the observed number of cases with teriparatide exposure was similar to the expected number of cases in the osteoporosis and general population patients, the point estimates for the IRR were 1 and 1.3, respectively, indicating no observed increase in risk.