Evidence map›Paper›PMID 26092063›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2015

FRAX and the effect of teriparatide on vertebral and non-vertebral fracture.

N C Harvey, J A Kanis, A Odén, R T Burge, B H Mitlak, H Johansson, E V McCloskey

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
4.1field-weighted citation impact, top 7% of its field
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

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. European guidance for the diagnosis and management of osteoporosis in postmenopausal women.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019
    Guideline
  2. Pooled it
  3. Menopausal hormone therapy reduces the risk of fracture regardless of falls risk or baseline FRAX probability-results from the Women's Health Initiative hormone therapy trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022
    Trial
  4. Romosozumab efficacy on fracture outcomes is greater in patients at high baseline fracture risk: a post hoc analysis of the first year of the frame study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    Trial
  5. Trial
  6. The Effect of Abaloparatide-SC on Fracture Risk Is Independent of Baseline FRAX Fracture Probability: A Post Hoc Analysis of the ACTIVE Study.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2017
    Trial
  7. Revised Swedish FRAX models and the establishment of age-dependent intervention thresholds.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Global impact of COVID-19 on non-communicable disease management: descriptive analysis of access to FRAX fracture risk online tool for prevention of osteoporotic fractures.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    Article
  15. Ovariectomy Activates Chronic Low-Grade Inflammation Mediated by Memory T Cells, Which Promotes Osteoporosis in Mice.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2020
    Article
  16. A brief history of FRAX.Archives of osteoporosis · 2018
    Review
  17. Review of the guideline of the American College of Physicians on the treatment of osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2018
    Review
  18. Management of Patients With High Baseline Hip Fracture Risk by FRAX Reduces Hip Fractures-A Post Hoc Analysis of the SCOOP Study.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2018
    Article
  19. Identification and management of patients at increased risk of osteoporotic fracture: outcomes of an ESCEO expert consensus meeting.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2017
    Article
  20. High Serum SHBG Predicts Incident Vertebral Fractures in Elderly Men.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2016
    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

7 authors at 3 institutions in 2 countries.

N C HarveyMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.
J A KanisCentre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK. w.j.pontefract@sheffield.ac.uk.
A OdénCentre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.
R T BurgeBone, Muscle and Joint Platform, Eli Lilly and Company, Indianapolis, IN, USA.
B H MitlakBone, Muscle and Joint Platform, Eli Lilly and Company, Indianapolis, IN, USA.
H JohanssonCentre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.
E V McCloskeyCentre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.
University of Sheffield · GBEli Lilly (United States) · USUniversity of Southampton · GB

Funding

Medical Research Council MC_U147585827Medical Research Council MC_UP_A620_1014Medical Research Council MC_UU_12011/1Medical Research Council MR/K006312/1
6 · The paper itself

Abstract

unlabelledDaily teriparatide injections have been shown to reduce vertebral and non-vertebral fractures. Here, we demonstrate that the magnitude of fracture risk reduction is independent of baseline fracture probability assessed by FRAX.

introductionDaily administration of 20 or 40 μg teriparatide has been shown to significantly decrease the risk of vertebral and non-vertebral fracture compared with placebo. The aim of the present study was to evaluate fracture risk assessed at baseline using the FRAX® tool and to determine the efficacy of teriparatide as a function of baseline fracture risk.

methodsOne thousand six hundred thirty-seven postmenopausal women in the pivotal phase three trial, randomly assigned to receive placebo (n = 544), teriparatide 20 μg per day (n = 541) or teriparatide 40 μg per day (n = 552), were studied. Baseline clinical risk factors were entered into country-specific FRAX models to compute the 10-year probability of major osteoporotic fractures with or without input of femoral neck BMD. Because there was no difference in effect of 20 and 40 μg teriparatide daily on fracture occurrence, the two active groups were merged. The interaction between probability of a major fracture and treatment efficacy was examined by Poisson regression.

resultsThe 10-year probability of major osteoporotic fractures (with BMD) ranged from 2.2-67.2 %. Treatment with teriparatide was associated with a 37 % decrease in all non-vertebral fractures (95 % CI 10-56 %) and a 56 % decrease in low-energy non-vertebral fractures (95 % CI 24-75 %) compared with placebo. The risk of morphometric vertebral fractures decreased significantly by 66 % (95 % CI 50-77 %). Hazard ratios for the effect of teriparatide on the fracture outcome did not change significantly with increasing fracture probability (p > 0.30). Similar findings were noted for the interaction when BMD was excluded from the FRAX model, or when probability of hip fracture was used as the marker of baseline risk.

conclusionWe conclude that teriparatide significantly decreases the risk of non-vertebral and morphometric vertebral fractures in women by a similar extent, irrespective of baseline fracture probability.

Indexed as

AgedBone DensityBone Density Conservation AgentsDouble-Blind MethodDrug Administration ScheduleFemaleHip FracturesHumansMiddle AgedOsteoporosis, PostmenopausalOsteoporotic FracturesRisk AssessmentRisk FactorsSpinal FracturesTeriparatideBone Density Conservation AgentsTeriparatideBMDEpidemiologyFractureFRAXInteractionOsteoporosisRandomised controlled trialTeriparatide

Identifiers

PMID26092063
PMCPMC4913866
OpenAlexW373968353

What OpenQuestion holds

Textmetadata
LicenceTDM
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.