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Vertebral Fractures After Discontinuation of Denosumab: A Post Hoc Analysis of the Randomized Placebo‐Controlled FREEDOM Trial and Its Extension
Journal of bone and mineral research, 2018-02, Vol.33 (2), p.190-198
Cummings, Steven R
Ferrari, Serge
Eastell, Richard
Gilchrist, Nigel
Jensen, Jens‐Erik Beck
McClung, Michael
Roux, Christian
Törring, Ove
Valter, Ivo
Wang, Andrea T
Brown, Jacques P
2018
Volltextzugriff (PDF)
Details
Autor(en) / Beteiligte
Cummings, Steven R
Ferrari, Serge
Eastell, Richard
Gilchrist, Nigel
Jensen, Jens‐Erik Beck
McClung, Michael
Roux, Christian
Törring, Ove
Valter, Ivo
Wang, Andrea T
Brown, Jacques P
Titel
Vertebral Fractures After Discontinuation of Denosumab: A Post Hoc Analysis of the Randomized Placebo‐Controlled FREEDOM Trial and Its Extension
Ist Teil von
Journal of bone and mineral research, 2018-02, Vol.33 (2), p.190-198
Ort / Verlag
United States: Wiley Subscription Services, Inc
Erscheinungsjahr
2018
Quelle
Wiley-Blackwell Full Collection
Beschreibungen/Notizen
ABSTRACT Denosumab reduces bone resorption and vertebral and nonvertebral fracture risk. Denosumab discontinuation increases bone turnover markers 3 months after a scheduled dose is omitted, reaching above‐baseline levels by 6 months, and decreases bone mineral density (BMD) to baseline levels by 12 months. We analyzed the risk of new or worsening vertebral fractures, especially multiple vertebral fractures, in participants who discontinued denosumab during the FREEDOM study or its Extension. Participants received ≥2 doses of denosumab or placebo Q6M, discontinued treatment, and stayed in the study ≥7 months after the last dose. Of 1001 participants who discontinued denosumab during FREEDOM or Extension, the vertebral fracture rate increased from 1.2 per 100 participant‐years during the on‐treatment period to 7.1, similar to participants who received and then discontinued placebo (n = 470; 8.5 per 100 participant‐years). Among participants with ≥1 off‐treatment vertebral fracture, the proportion with multiple (>1) was larger among those who discontinued denosumab (60.7%) than placebo (38.7%; p = 0.049), corresponding to a 3.4% and 2.2% risk of multiple vertebral fractures, respectively. The odds (95% confidence interval) of developing multiple vertebral fractures after stopping denosumab were 3.9 (2.1–7. 2) times higher in those with prior vertebral fractures, sustained before or during treatment, than those without, and 1.6 (1.3–1.9) times higher with each additional year of off‐treatment follow‐up; among participants with available off‐treatment total hip (TH) BMD measurements, the odds were 1.2 (1.1–1.3) times higher per 1% annualized TH BMD loss. The rates (per 100 participant‐years) of nonvertebral fractures during the off‐treatment period were similar (2.8, denosumab; 3.8, placebo). The vertebral fracture rate increased upon denosumab discontinuation to the level observed in untreated participants. A majority of participants who sustained a vertebral fracture after discontinuing denosumab had multiple vertebral fractures, with greatest risk in participants with a prior vertebral fracture. Therefore, patients who discontinue denosumab should rapidly transition to an alternative antiresorptive treatment. Clinicaltrails.gov: NCT00089791 (FREEDOM) and NCT00523341 (Extension). © 2017 American Society for Bone and Mineral Research.
Sprache
Englisch
Identifikatoren
ISSN: 0884-0431, 1523-4681
eISSN: 1523-4681
DOI: 10.1002/jbmr.3337
Titel-ID: cdi_swepub_primary_oai_prod_swepub_kib_ki_se_137618811
Format
–
Schlagworte
Aged
,
Aged, 80 and over
,
Bone Density
,
Bone mineral density
,
BONE RESORPTION
,
Bone turnover
,
DENOSUMAB
,
Denosumab - therapeutic use
,
DISCONTINUATION
,
Female
,
Fractures
,
Hip
,
Humans
,
Immunotherapy
,
Logistic Models
,
Medicin och hälsovetenskap
,
Middle Aged
,
Monoclonal antibodies
,
MULTIPLE VERTEBRAL FRACTURES
,
Multivariate Analysis
,
Osteoporosis, Postmenopausal - drug therapy
,
Osteoporosis, Postmenopausal - physiopathology
,
Spinal Fractures - drug therapy
,
Spinal Fractures - epidemiology
,
Spinal Fractures - physiopathology
,
Vertebrae
,
VERTEBRAL FRACTURES
,
Withholding Treatment
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