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Forsteo ® (teriparatide)
This information is intended for UK registered healthcare professionals only in response to your search for information. For current information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Use of Forsteo® (Teriparatide) in patients with history of cancer
Patients with a history of cancer were not specifically recruited for any teriparatide clinical trials. Teriparatide use should be avoided in patients who are at increased baseline risk of osteosarcoma.
Content overview
Were patients with a history of cancer included in clinical trials?
Patients with a history of cancer were not specifically recruited for any teriparatide clinical trials.1
Exclusion criteria for teriparatide clinical trials included
- patients with a history of carcinoma in the previous 5 years, or
- patients currently being evaluated for suspected carcinoma.1
Patients allowed to participate in teriparatide clinical trials included
- patients who had undergone excision of superficial lesions of the skin (eg, basal cell or squamous cell carcinoma), or
- patients who had a history of carcinoma in situ of the cervix or uterus.1
The incidence of cancer that occurred in patients in teriparatide clinical trials is summarized in the Incidence of cancer in teriparatide clinical trials.
What should be considered before using teriparatide in patients with a history of cancer?
Healthcare professionals should carefully weigh the intended benefits of teriparatide versus the theoretical risks in patients with a history of cancer such as
- the possibility of the presence of micrometastatic tumor cells in the bone marrow even after several years of the patient appearing to be cancer-free, and
- the potential effect of a high-bone-turnover state on those cells.2
A stimulatory effect of teriparatide on hematopoietic stem cells is also a theoretical concern for patients with a history of hematologic cancers.2
Before prescribing teriparatide to a patient with a history of cancer, the health care professional should consider
- the type of previous cancer
- the risk of bone metastases, and
- the length of time the patient has been in remission.3
Avoid teriparatide use in patients who are at an increased baseline risk for osteosarcoma. These include patients with open epiphyses (pediatric and young adult patients) and hereditary disorders predisposing to osteosarcoma.1,4,5
Contraindications for teriparatide treatment
According to the Summary of Product Characteristics of Forsteo, teriparatide is contraindicated in:5
- Metabolic bone diseases (including hyperparathyroidism and Paget’s disease of the bone) other than primary osteoporosis or glucocorticoid-induced osteoporosis.
- Prior external beam or implant radiation therapy to the skeleton
- Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide
For a full list of contraindications, please refer to the summary of product characteristics of Forsteo.5
Osteosarcoma reported in animals and humans
We summarized the incidence of osteosarcoma in animals in Osteosarcoma in animals.
A summary of osteosarcoma among teriparatide-treated patients in the postmarketing period and in the Teriparatide GHBX Osteosarcoma Surveillance Program can be found in Osteosarcoma in Humans.
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What are the most common cancers that metastasize to the bone?
The most common cancers to metastasize to the bone (in decreasing order of frequency) are
- breast
- prostate
- lung
- colon
- stomach
- bladder
- uterus
- rectum
- thyroid, and
- kidney.3
Additional factors affecting the risk of bone metastasis include
- Tumor-node-metastasis (TNM) classification, and
- estrogen receptor status in patients with a history of breast cancer.3
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References
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Farooki A, Fornier M, Girotra M. Anabolic therapies for osteoporosis. N Engl J Med. 2007;357(23):2410-2411. http://dx.doi.org/10.1056/NEJMc076405
3File E, Deal C. Clinical update on teriparatide. Curr Rheumatol Rep. 2009;11(3):169-176. https://doi.org/10.1007/s11926-009-0023-3
4Forteo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.
5Forsteo [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
6Vahle JL, Sato M, Long GG, et al. Skeletal changes in rats given daily subcutaneous injections of recombinant human parathyroid hormone (1-34) for 2 years and relevance to human safety. Toxicol Pathol. 2002;30(3):312-321. http://dx.doi.org/10.1080/01926230252929882
7Vahle JL, Long GG, Sandusky G, et al. Bone neoplasms in F344 rats given teriparatide [rhPTH(1-34)] are dependent on duration of treatment and dose. Toxicol Pathol. 2004;32(4):426-438. http://dx.doi.org/10.1080/01926230490462138
8Tashjian AH Jr, Chabner BA. 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. 2002;17(7):1151-1161. http://dx.doi.org/10.1359/jbmr.2002.17.7.1151
9Tashjian AH Jr, Goltzman D. On the interpretation of rat carcinogenicity studies for human PTH(1-34) and human PTH(1-84). J Bone Miner Res. 2008;23(6):803-811. http://dx.doi.org/10.1359/jbmr.080208
10Mirabello L, Troisi RJ, Savage SA. International osteosarcoma incidence patterns in children and adolescents, middle ages and elderly persons. Int J Cancer. 2009;125(1):229-234. https://doi.org/10.1002/ijc.24320
11Andrews EB, Gilsenan AW, Midkiff K, et al. The US postmarketing surveillance study of adult osteosarcoma and teriparatide: study design and findings from the first 7 years. J Bone Miner Res. 2012;27(12):2429-2437. https://doi.org/10.1002/jbmr.1768
12Gilsenan A, Midkiff K, Harris D, et al. Teriparatide did not increase adult osteosarcoma incidence in a 15-year US postmarketing surveillance study. J Bone Miner Res. 2021;36(2):244-251. https://doi.org/10.1002/jbmr.4188
13Midkiff KD. Forteo/Forsteo post-approval osteosarcoma surveillance study (Study B3D-MC-GHBX). Postauthorization safety study information. 2014. http://www.encepp.eu/encepp/openAttachment/studyResult/8539
14Gilsenan A, Harding A, Kellier-Steele N, et al. The Forteo Patient Registry linkage to multiple state cancer registries: study design and results from the first 8 years. Osteoporos Int. 2018;29(10):2335-2343. https://doi.org/10.1007/s00198-018-4604-8
15Gilsenan A, Harris D, Reynolds M, et al. Long-term cancer surveillance: results from the Forteo Patient Registry Surveillance Study. Osteoporos Int. 2021;32(4):645-651. https://doi.org/10.1007/s00198-020-05718-0
16Gilsenan A, Midkiff K, Harris D, et al. Assessing the incidence of osteosarcoma among teriparatide users based on Medicare Part D and US State Cancer Registry Data. Pharmacoepidemiol Drug Saf. 2020;29(12):1616-1626. https://doi.org/10.1002/pds.5103
17Kellier-Steele N, Casso D, Anderson A, et al. Assessing the incidence of osteosarcoma among teriparatide-treated patients using linkage of commercial pharmacy and state cancer registry data, contributing to the removal of boxed warning and other labeling changes. Bone. 2022;160:116394. https://doi.org/10.1016/j.bone.2022.116394
18Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001;344(19):1434-1441. http://dx.doi.org/10.1056/nejm200105103441904
19Orwoll ES, Scheele WH, Paul S, et al. The effect of teriparatide [human parathyroid hormone (1-34)] therapy on bone density in men with osteoporosis. J Bone Miner Res. 2003;18(1):9-17. https://dx.doi.org/10.1359/jbmr.2003.18.1.9
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Appendix
Osteosarcoma in animals
In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration.6,7 However, it was concluded that the rat findings do not predict an increased risk of osteosarcoma in humans above the background incidence due to differences in
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Osteosarcoma in Humans
In the postmarketing period, cases of bone tumor and osteosarcoma have been reported rarely in patients who used teriparatide.1
The cumulative number of spontaneous reports with a pathology-confirmed diagnosis of osteosarcoma does not exceed what would be predicted based on background incidence alone.1
The global incidence of osteosarcoma in the general population over the age of 60 years is approximately 4.6 cases per million per year for men and 3.3 cases per million per year for women.10
A comprehensive program including 5 different studies, the GHBX program, was designed with input from regulatory authorities to obtain data on the incidence rate of osteosarcoma among teriparatide-treated patients (Teriparatide GHBX Osteosarcoma Surveillance Program).1,11-17
Study Identifier |
Study/Diagnostic Years |
Methodology |
Main Results |
The US OS Surveillance Study; case series; 2003-2016 |
Identified incident cases of OS among adults (≥40 y) using 30 US cancer registries and determined through interview of patients or proxies if the patients had a history of TPTD exposure before OS diagnosis |
|
|
Forteo/Forsteo Post-Approval Osteosarcoma Surveillance Study; companion case series study in 5 Nordic countries; 2004-2013 |
Identified incident cases of OS among adults (≥40 y) using the SSG registry and the Finnish and Swedish National Cancer Registries and determined through their medical records if the patients had a history of TPTD exposure before OS diagnosis |
|
|
The FPR Surveillance Study; prospective voluntary registry in the United States; 2009-2019 |
TPTD-treated patients (≥18 y) enrolled in the FPR were linked annually (2010-2019) with 42 state cancer registries to ascertain new cases of OS in TPTD-exposed patients |
|
|
Teriparatide Medicare Linkage Study; US population–based comparative cohort study; 2007-2014 |
Compared the incidence of OS between TPTD users and TPTD non-users (≥65 y) by linking Medicare Part D data with OS data from 26 state cancer registries |
|
|
Commercial pharmacy claims study; US population–based comparative cohort study; 2005-2014 |
Compared the incidence of OS between TPTD users and TPTD non-users with OP, and in the GP (≥18 y), by linking IQVIA LRx pharmacy database data with OS data from 29 state cancer registries The study cohorts were |
|
Abbreviations: FPR = Forteo Patient Registry; GP = general population; LRx = Longitudinal Prescription database; OP = osteoporosis; OS = osteosarcoma; SSG = Scandinavian Sarcoma Group; TPTD = teriparatide.
aTo protect patient privacy, nonzero cell counts <11 cannot be disclosed for Medicare data; thus, the exact number of cases in the comparator cohort cannot be reported since it is more than 0 but less than 11.
bTPTD-OP cohort was formed by matching TPTD-treated patients (up to 1:2) to OP patients not treated with TPTD.
cTPTD-GP cohort was formed by matching TPTD-treated patients (up to 1:4) to patients in the GP not treated with TPTD.
The study results suggest a similar risk for osteosarcoma between teriparatide users and their comparators. However, the interpretation of the study results calls for caution due to the limitations of the data sources, which do not allow for complete measurement and control for confounders.1,4
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Incidence of cancer in teriparatide clinical trials
Overall, 40 women developed cancer in the Fracture Prevention Trial. The incidence of cancer was
- 4% in the placebo group,
- 2% in the 20 mcg teriparatide group (p=.02), and
- 2% in the 40 mcg teriparatide group (p=.07).18
During a phase 3 study analyzing the efficacy of teriparatide in men (n=437), cancer occurred in
- 3 men in the placebo group
- 3 men in the 20 mcg group, and
- 0 men in the 40 mcg group.19
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Date of Last Review: 17 August 2023