Real‐World Effectiveness of Osteoporosis Medications in France: A Nationwide Cohort Study

ABSTRACT Although drugs for osteoporosis have been demonstrated to be effective in reducing fracture risk in placebo‐controlled clinical trials, data on effectiveness in real‐world practice is limited. Data from the French national health insurance claims database (SNDS) were used to follow five coh...

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Main Authors: Pauline Bosco‐Lévy, Karine Briot, Nadia Mehsen‐Cetre, James O'Kelly, Gaëlle Désaméricq, Abdelilah Abouelfath, Régis Lassalle, Angela Grelaud, Adeline Grolleau, Patrick Blin, Cécile Droz‐Perroteau
Format: Article
Language:English
Published: Wiley 2023-09-01
Series:JBMR Plus
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Online Access:https://doi.org/10.1002/jbm4.10789
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author Pauline Bosco‐Lévy
Karine Briot
Nadia Mehsen‐Cetre
James O'Kelly
Gaëlle Désaméricq
Abdelilah Abouelfath
Régis Lassalle
Angela Grelaud
Adeline Grolleau
Patrick Blin
Cécile Droz‐Perroteau
author_facet Pauline Bosco‐Lévy
Karine Briot
Nadia Mehsen‐Cetre
James O'Kelly
Gaëlle Désaméricq
Abdelilah Abouelfath
Régis Lassalle
Angela Grelaud
Adeline Grolleau
Patrick Blin
Cécile Droz‐Perroteau
author_sort Pauline Bosco‐Lévy
collection DOAJ
description ABSTRACT Although drugs for osteoporosis have been demonstrated to be effective in reducing fracture risk in placebo‐controlled clinical trials, data on effectiveness in real‐world practice is limited. Data from the French national health insurance claims database (SNDS) were used to follow five cohorts of women aged ≥55 years after initiating treatment for ≥6 months with either denosumab, zoledronic acid, oral bisphosphonates, raloxifene, or teriparatide in 2014–2016. Fracture incidence was compared within each cohort between the 3 months following initiation (baseline fracture risk) and the 12month, 18month, and 24 month postinitiation periods. Data are presented as incidence rate ratios (IRRs) with their 95% confidence intervals (CIs)s. Overall, 67,046 women were included in the denosumab cohort, 52,914 in the oral bisphosphonate cohort, 41,700 in the zoledronic acid cohort, 11,600 in the raloxifene cohort, and 7510 in the teriparatide cohort. The baseline vertebral fracture rate ranged from 1.74 per 1000 person years (‰PY) in the raloxifene cohort to 34.75‰PY in the teriparatide cohort, and the baseline hip fracture rate from 0.70‰PY in the raloxifene cohort to 10.52‰PY in the zoledronic acid cohort. Compared with the baseline fracture rate, vertebral fractures involving hospitalization were significantly reduced in the 3–24–month postinitiation period with denosumab (IRR 0.6; 95% CI, 0.5–0.7), zoledronic acid (IRR 0.4; 95% CI, 0.3–0.4), teriparatide (IRR 0.3; 95% CI, 0.2–0.5), and oral bisphosphonates (IRR 0.6; 95% CI, 0.4–0.8). Hip fracture incidence was reduced with denosumab (IRR 0.8; 95% CI, 0.6–0.9), but higher for oral bisphosphonates (IRR 1.7; 95% CI, 1.2–2.3); no significant change in hip fracture rate was observed for zoledronic acid, teriparatide, or raloxifene. A reduction in nonvertebral, non‐hip fracture incidence was observed only in the denosumab cohort (IRR 0.8; 95% CI, 0.7–0.9). These findings indicate that treatment with osteoporosis drugs is effective in the real‐world setting. © 2023 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.
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spelling doaj.art-02a2438e50814933a76f58e93cf597f22023-09-11T11:34:52ZengWileyJBMR Plus2473-40392023-09-0179n/an/a10.1002/jbm4.10789Real‐World Effectiveness of Osteoporosis Medications in France: A Nationwide Cohort StudyPauline Bosco‐Lévy0Karine Briot1Nadia Mehsen‐Cetre2James O'Kelly3Gaëlle Désaméricq4Abdelilah Abouelfath5Régis Lassalle6Angela Grelaud7Adeline Grolleau8Patrick Blin9Cécile Droz‐Perroteau10Bordeaux PharmacoEpi, INSERM CIC‐P 1401 Université de Bordeaux Bordeaux FranceService de rhumatologie Hôpital Cochin Paris FranceService de rhumatologie CHU Pellegrin‐Tripode Bordeaux FranceAmgen Ltd Cambridge UKAmgen SAS Boulogne Billancourt FranceBordeaux PharmacoEpi, INSERM CIC‐P 1401 Université de Bordeaux Bordeaux FranceBordeaux PharmacoEpi, INSERM CIC‐P 1401 Université de Bordeaux Bordeaux FranceBordeaux PharmacoEpi, INSERM CIC‐P 1401 Université de Bordeaux Bordeaux FranceBordeaux PharmacoEpi, INSERM CIC‐P 1401 Université de Bordeaux Bordeaux FranceBordeaux PharmacoEpi, INSERM CIC‐P 1401 Université de Bordeaux Bordeaux FranceBordeaux PharmacoEpi, INSERM CIC‐P 1401 Université de Bordeaux Bordeaux FranceABSTRACT Although drugs for osteoporosis have been demonstrated to be effective in reducing fracture risk in placebo‐controlled clinical trials, data on effectiveness in real‐world practice is limited. Data from the French national health insurance claims database (SNDS) were used to follow five cohorts of women aged ≥55 years after initiating treatment for ≥6 months with either denosumab, zoledronic acid, oral bisphosphonates, raloxifene, or teriparatide in 2014–2016. Fracture incidence was compared within each cohort between the 3 months following initiation (baseline fracture risk) and the 12month, 18month, and 24 month postinitiation periods. Data are presented as incidence rate ratios (IRRs) with their 95% confidence intervals (CIs)s. Overall, 67,046 women were included in the denosumab cohort, 52,914 in the oral bisphosphonate cohort, 41,700 in the zoledronic acid cohort, 11,600 in the raloxifene cohort, and 7510 in the teriparatide cohort. The baseline vertebral fracture rate ranged from 1.74 per 1000 person years (‰PY) in the raloxifene cohort to 34.75‰PY in the teriparatide cohort, and the baseline hip fracture rate from 0.70‰PY in the raloxifene cohort to 10.52‰PY in the zoledronic acid cohort. Compared with the baseline fracture rate, vertebral fractures involving hospitalization were significantly reduced in the 3–24–month postinitiation period with denosumab (IRR 0.6; 95% CI, 0.5–0.7), zoledronic acid (IRR 0.4; 95% CI, 0.3–0.4), teriparatide (IRR 0.3; 95% CI, 0.2–0.5), and oral bisphosphonates (IRR 0.6; 95% CI, 0.4–0.8). Hip fracture incidence was reduced with denosumab (IRR 0.8; 95% CI, 0.6–0.9), but higher for oral bisphosphonates (IRR 1.7; 95% CI, 1.2–2.3); no significant change in hip fracture rate was observed for zoledronic acid, teriparatide, or raloxifene. A reduction in nonvertebral, non‐hip fracture incidence was observed only in the denosumab cohort (IRR 0.8; 95% CI, 0.7–0.9). These findings indicate that treatment with osteoporosis drugs is effective in the real‐world setting. © 2023 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.https://doi.org/10.1002/jbm4.10789ANTIRESORPTIVE MEDICATIONSFRACTURE INCIDENCEHEALTHCARE DATABASEOSTEOPOROSIS
spellingShingle Pauline Bosco‐Lévy
Karine Briot
Nadia Mehsen‐Cetre
James O'Kelly
Gaëlle Désaméricq
Abdelilah Abouelfath
Régis Lassalle
Angela Grelaud
Adeline Grolleau
Patrick Blin
Cécile Droz‐Perroteau
Real‐World Effectiveness of Osteoporosis Medications in France: A Nationwide Cohort Study
JBMR Plus
ANTIRESORPTIVE MEDICATIONS
FRACTURE INCIDENCE
HEALTHCARE DATABASE
OSTEOPOROSIS
title Real‐World Effectiveness of Osteoporosis Medications in France: A Nationwide Cohort Study
title_full Real‐World Effectiveness of Osteoporosis Medications in France: A Nationwide Cohort Study
title_fullStr Real‐World Effectiveness of Osteoporosis Medications in France: A Nationwide Cohort Study
title_full_unstemmed Real‐World Effectiveness of Osteoporosis Medications in France: A Nationwide Cohort Study
title_short Real‐World Effectiveness of Osteoporosis Medications in France: A Nationwide Cohort Study
title_sort real world effectiveness of osteoporosis medications in france a nationwide cohort study
topic ANTIRESORPTIVE MEDICATIONS
FRACTURE INCIDENCE
HEALTHCARE DATABASE
OSTEOPOROSIS
url https://doi.org/10.1002/jbm4.10789
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