Abstract
The Osteosarcoma Surveillance Study, an ongoing 15-year surveillance study initiated in 2003, is a postmarketing commitment to the United States (US) Food and Drug Administration to evaluate a potential association between teriparatide, rhPTH(1–34), a recombinant human parathyroid hormone analog (self-injectable medication to treat osteoporosis), and development of osteosarcoma in response to a finding from preclinical (animal) studies. Incident cases of primary osteosarcoma diagnosed in adults (aged ≥40 years) on or after January 1, 2003, are identified through population-based state, regional, and comprehensive cancer center registries in the US. Information on possible prior treatment with teriparatide, on demographics, and on risk factors is ascertained by patient or proxy telephone interview after patient consent. Between June 2004 and September 30, 2011, 1448 cases (diagnosed 2003 to 2009) were identified by participating cancer registries (estimated to be 62% of all adult cases in the US for that time period); 549 patients or proxies were interviewed. Interviewed patients were similar to noninterviewed patients with regard to mean age, sex, race, and geographical distribution and tumor type and site of tumor. Mean age of those interviewed was 61 years, 46% were female, 86% were white, and 77% were alive when the case was reported to the study investigators. Data collected in the study provide descriptive information on a large number of adults with osteosarcoma, an uncommon malignant bone tumor. After 7 years of the study, there were no osteosarcoma patients who had a prior history of teriparatide treatment. Thus, approximately halfway through this 15-year study, the study has not detected a pattern indicative of a causal association between teriparatide treatment and osteosarcoma in humans. © 2012 American Society for Bone and Mineral Research.
Highlights
The Osteosarcoma Surveillance Study was established in 2003 as a postmarketing commitment to the Food and Drug Administration (FDA) for teriparatide, a recombinant human parathyroid hormone (PTH) analog, to evaluate a potential association between teriparatide and osteosarcoma in humans based on preclinical findings
The 15-year study was designed to detect a doubling of the background rate of osteosarcoma, if it occurs, which would result in one additional case per 313,000 treated patients
We have interviewed 549 adults with osteosarcoma and none reported prior exposure to teriparatide
Summary
The Osteosarcoma Surveillance Study was established in 2003 as a postmarketing commitment to the Food and Drug Administration (FDA) for teriparatide, a recombinant human parathyroid hormone (PTH) analog, to evaluate a potential association between teriparatide and osteosarcoma in humans based on preclinical (animal) findings. Teriparatide stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. It is indicated for treatment of osteoporosis in postmenopausal women at high risk for fracture and to increase their bone mass, to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, and for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. Subsequent studies demonstrated a ‘‘no-effect’’ dose in rats[2] and no bone tumors in a long-term study of cynomolgus monkeys,(3) the US product label contains a warning to physicians and patients about a potential risk of osteosarcoma and to use the product only in the absence of other risk factors for osteosarcoma (e.g., Paget’s disease of bone, prior radiation therapy, or children or young adults with open epiphyses) and to limit exposure to a maximum of 2 years.
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