JOURNAL OF BONE AND MINERAL RESEARCH
Volume 22, Number 2, 2007
Published online on November 13, 2006; doi: 10.1359/JBMR.061111
© 2007 American Society for Bone and Mineral Research
Letter to the Editor
Osteosarcoma and Teriparatide?
To the Editor:
We wish to update the medical literature regarding state-
ments that there have been no reports of osteosarcoma in
any patients treated with Forteo (Forsteo in Europe).(1,2)
Forteo is the trade name for teriparatide [rhPTH(1-34)]
20 ␮g/day, and its labeling includes warnings concerning
carcinogenicity assessments showing teriparatide caused os-
teosarcoma in rats in a manner dependent on both dose and
duration of treatment.(2–5) Since first commercial launch in
December 2002, Lilly has maintained a worldwide teripa-
ratide 20 ␮g/day safety monitoring program and has re-
cently identified one confirmed case of osteosarcoma in a
patient treated with Forteo.
A physician communicated the initial report of the case
to a Lilly sales representative. The patient was a postmeno-
pausal woman in her 70s with a complex past medical his-
tory. The history included osteoporosis with vertebral
fractures, and she was treated with Forteo in a manner
consistent with the label. Sometime after beginning her sec-
ond year of Forteo therapy, she was found to have meta-
static cancer. She subsequently died, and no autopsy was
performed. The primary cancer site was never identified.
The initial clinical impression was lung cancer with metas-
tases. The case was referred to a pathology consultant,
whose differential diagnosis included several tumor types,
including an osteosarcoma variant. Lilly submitted the bi-
opsy materials to another bone pathology expert who com-
municated on June 29, 2006 that he concluded the lesion
was an osteosarcoma.
Causality between Forteo and the osteosarcoma in this
patient cannot be established, taking into account this was
a single case of >250,000 patients in the United States and
>300,000 patients worldwide treated with Forteo, the pa-
tient had a complex medical history, and the background
incidence of osteosarcoma in the general population of men
334
and women ⱖ60 years of age is 1 in 250,000 per year.(6) The
identification of this case does not change the risk/benefit
profile for Forteo. Given the known incidence in the gen-
eral population, very rare cases of osteosarcoma can be
expected, irrespective of treatment with Forteo. Lilly will
continue to monitor for any signal of increased risk of os-
teosarcoma in patients treated with Forteo relative to the
background incidence.
REFERENCES
1. Gold DT, Pantos BS, Masica DN, Misurski DA, Marcus R
2006 Initial experience with teriparatide in the United States.
Curr Med Res Opin 22:703–708.
2. Tashjian AH Jr, Gagel RF 2006 Teriparatide [human
PTH(1-34)]: 2.5 years of experience on the use and safety of
the drug for the treatment of osteoporosis. J Bone Miner Res
21:354–365.
3. Vahle JL, Sato M, Long GG, Young JK, Francis PC, Engel-
hardt JA, Westmore M, Ma L, Nold JB 2002 Skeletal changes
in rats given daily subcutaneous injections of recombinant hu-
man parathyroid hormone(1-34) for 2 years and relevance to
human safety. Toxicol Pathol 30:312–321.
4. Vahle JL, Long GG, Sandusky G, Westmore M, Ma YL, Sato
M 2004 Bone neoplasms in F344 rats given teriparatide
[rhPTH(1-34)] are dependent on duration of treatment and
dose. Toxicol Pathol 32:426–438.
5. Tashjian AH Jr, Chabner BA 2002 Commentary on clinical
safety of recombinant human parathyroid hormone 1-34 in the
treatment of osteoporosis in men and postmenopausal women.
J Bone Miner Res 17:1151–1161.
6. Surveillance Research Program National Cancer Institute
SEER*Stat Software, version 6.1.4. Available at www.seer.
cancer.gov/seerstat.
Kristine D Harper, John H Krege,
Robert Marcus, and Bruce H Mitlak
Lilly Research Labs
Eli Lilly and Company
Indianapolis, IN, USA