ArticlePharmacoepidemiology and drug safety2013
Design and methods of a postmarketing pharmacoepidemiology study assessing long-term safety of Prolia® (denosumab) for the treatment of postmenopausal osteoporosis.
Article in Pharmacoepidemiology and drug safety, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02520362 (Denosumab Global Safety Assessment Among Women With Postmenopausal Osteoporosis), which is not on this map. Cited by 15 papers.
What it found
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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.
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.
Denosumab Global Safety Assessment Among Women With Postmenopausal Osteoporosis (PMO), Men With Osteoporosis, and Men and Women Who Receive Prolia With Glucocorticoid Exposure in Multiple Observational Databases
Who cites it
15 citing papers in PubMed, 27 citations in OpenAlex.
- Leveraging Multi-National Observational Study in Post-Marketing Safety Assessment: Challenges and Strategies.Therapeutic innovation & regulatory science · 2025Article
- Denosumab and clinical outcomes among men with osteoporosis: a retrospective cohort study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025Article
- Positive Predictive Value of ICD-10 Codes for Identifying Hypocalcemia in Women with Postmenopausal Osteoporosis in Swedish Patient Register: A Validation Study.Clinical epidemiology · 2025Article
- Epidemiology of male osteoporosis in Denmark (1996-2018).Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2023Article
- Racial Disparities Exist in Outcomes After Major Fragility Fractures.Journal of the American Geriatrics Society · 2020Observational
- Article
- Tools and Methods for Real-World Evidence Generation: Pragmatic Trials, Electronic Consent, and Data Linkages.Rheumatic diseases clinics of North America · 2019Review
- The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE).BMJ (Clinical research ed.) · 2018Article
- Predictive values of diagnostic codes for identifying serious hypocalcemia and dermatologic adverse events among women with postmenopausal osteoporosis in a commercial health plan database.BMC health services research · 2018Article
- Denosumab for the treatment of osteoporosis.Osteoporosis and sarcopenia · 2017Review
- Positive predictive values of ICD-10 codes to identify incident acute pancreatitis and incident primary malignancy in the Scandinavian national patient registries among women with postmenopausal osteoporosis.Clinical epidemiology · 2017Article
- Article
- Assessment of off-label use of denosumab 60 mg injection during the early postmarketing period using health insurance claims data.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2016Article
- Denosumab: a review of its use in postmenopausal women with osteoporosis.Drugs & aging · 2014Review
- Effects of RANKL-Targeted Therapy in Immunity and Cancer.Frontiers in oncology · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo describe the rationale and methods for a prospective, open-cohort study assessing the long-term safety of Prolia(®) for treatment of postmenopausal osteoporosis (PMO) in postmarketing settings.
methodsData will be derived from United States Medicare, United Healthcare, and Nordic (Denmark, Sweden, Norway) national registries. Observation will begin on the date of first Prolia(®) regulatory approval (May 26, 2010) and continue for 10 years. Women with PMO will be identified by postmenopausal age, osteoporosis diagnosis, osteoporotic fracture, or osteoporosis treatment. Exposure to Prolia(®) and bisphosphonates will be updated during follow-up; exposure cohorts will be defined based on patient-years during which patients are on- or post-treatment. Nine adverse events (AEs) will be assessed based on diagnosis codes: osteonecrosis of the jaw (ONJ), atypical femoral fracture (AFF), fracture healing complications, hypocalcemia, infection, dermatologic AEs, acute pancreatitis, hypersensitivity, and new primary malignancy. Medical review will confirm selected potential cases of ONJ and AFF. Incidence rates (IRs) of AEs will be described overall and for exposure cohorts; multivariate Cox proportional hazard regression models will compare IRs of AEs across exposure cohorts. Utilization patterns of Prolia(®) for approved, and unapproved indications will be described.
conclusionThis study is based on comprehensive preliminary research and considers methodological challenges specific to the study population. The integrated data systems used in this regulatory committed program can serve as a powerful data resource to assess diverse and rare AEs over time.
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