Evidence map›Paper›PMID 29978254›Full record

ArticleOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2018

The Forteo Patient Registry linkage to multiple state cancer registries: study design and results from the first 8 years.

A Gilsenan, A Harding, N Kellier-Steele, D Harris, K Midkiff, E Andrews

Abstract read
In one paragraph

Article in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Long-term and sequential treatment for osteoporosis.Nature reviews. Endocrinology · 2023
    Review
  6. Review
  7. Review
  8. Repurposed and investigational disease-modifying drugs in osteoarthritis (DMOADs).Therapeutic advances in musculoskeletal disease · 2022
    Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Teriparatide Did Not Increase Adult Osteosarcoma Incidence in a 15-Year US Postmarketing Surveillance Study.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2021
    Article
  14. Review
  15. Article
  16. Safety and efficacy of teriparatide treatment for severe osteoporosis in patients with Duchenne muscular dystrophy.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2020
    Article
  17. Article
  18. Breast Cancer and Microcalcifications: An Osteoimmunological Disorder?International journal of molecular sciences · 2020
    Review
  19. High fracture risk patients with glucocorticoid-induced osteoporosis should get an anabolic treatment first.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2020
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

A GilsenanRTI Health Solutions, 200 Park Offices Drive, P.O. Box 12194, Research Triangle Park, NC, 27709, USA. agilsenan@rti.org.ORCID http://orcid.org/0000-0002-9266-1417
A HardingRTI Health Solutions, 200 Park Offices Drive, P.O. Box 12194, Research Triangle Park, NC, 27709, USA.
N Kellier-SteeleEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
D HarrisRTI Health Solutions, 200 Park Offices Drive, P.O. Box 12194, Research Triangle Park, NC, 27709, USA.
K MidkiffRTI Health Solutions, 200 Park Offices Drive, P.O. Box 12194, Research Triangle Park, NC, 27709, USA.
E AndrewsRTI Health Solutions, 200 Park Offices Drive, P.O. Box 12194, Research Triangle Park, NC, 27709, USA.

Funding

Eli Lilly and Company Not applicable
6 · The paper itself

Abstract

The Forteo Patient Registry (FPR) aims to estimate the incidence of osteosarcoma in US patients treated with teriparatide. Enrollment began in 2009 and will continue through 2019, with linkage planned through 2024. To date, no incident cases of osteosarcoma have been identified among patients registered in the FPR.

introductionThe Forteo Patient Registry (FPR) was established in 2009 to estimate the incidence of osteosarcoma in US patients treated with teriparatide. The objective of this paper is to describe study methods, challenges encountered, and progress to date.

methodsThe FPR is a prospective US registry designed to link data from participants annually with state cancer registries. Patient enrollment is planned for 10 years (2009-2019) and annual linkage with US state cancer registries for 15 years (2010-2024). All US state cancer registries and DC were invited to participate. Patients are recruited using pre-enrollment materials included in teriparatide device packaging, kits, and brochures distributed by health-care providers; a toll-free number; and a study website. A linkage algorithm is used to match data from enrolled participants with cancer registry data.

resultsFor the eighth annual linkage in 2017, information necessary for linkage with 63,270 patients in the FPR was submitted to each of the 42 participating registries. These patients contributed approximately 242,782 person-years of follow-up. A total of 5268 adult osteosarcoma cases diagnosed since January 1, 2009, were available for linkage from participating state cancer registries. To date, no incident cases of osteosarcoma have been identified among patients registered in the FPR.

conclusionsBased on the estimated 242,782 person-years of observation as of the eighth annual linkage and projecting current enrollment rate to study end in 2024, it is anticipated that the completed study will be able to detect a fourfold increase in the risk of osteosarcoma if one exists.

Indexed as

AdolescentAdultAgedAged, 80 and overBone Density Conservation AgentsBone NeoplasmsFemaleHumansMaleMedical Record LinkageMiddle AgedOsteosarcomaPatient SelectionProduct Surveillance, PostmarketingRegistriesResearch DesignBone Density Conservation AgentsTeriparatideLinkageOsteosarcomaRegistryTeriparatideUnited States

Identifiers

PMID29978254
PMCPMC6154045

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.