Evidence map›Paper›PMID 26092062›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

Efficacy of weekly teriparatide does not vary by baseline fracture probability calculated using FRAX.

N C Harvey, J A Kanis, A Odén, T Nakamura, M Shiraki, T Sugimoto, T Kuroda, H Johansson, E V McCloskey

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized 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 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 pooled it
3.8field-weighted citation impact, top 8% 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

18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Guideline
  4. 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
  5. 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
  6. 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
  7. 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
  8. Review
  9. Review
  10. Article
  11. An assessment of intervention thresholds for very high fracture risk applied to the NOGG guidelines : A report for the National Osteoporosis Guideline Group (NOGG).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
  12. Risk of subsequent fracture after prior fracture among older 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
    Article
  13. A brief history of FRAX.Archives of osteoporosis · 2018
    Review
  14. 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
  15. 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
  16. Article
  17. 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
  18. Review
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

9 authors at 6 institutions in 2 countries.

N C HarveyMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.
J A Kanis
A Odén
T Nakamura
M Shiraki
T Sugimoto
T Kuroda
H Johansson
E V McCloskey
University of Sheffield · GBAsahi Kasei (Japan) · JPMinebeaMitsumi (Japan) · JPMRC Lifecourse Epidemiology Unit · GBNational Center for Global Health and Medicine · JPShimane University · JP

Funding

Arthritis Research UK 17702Department of Health HTA/10/33/04Medical Research Council G0400491Medical Research Council MC_U147585819Medical Research Council MC_U147585824Medical 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

unlabelledThe aim of this study was to determine the efficacy of once-weekly teriparatide as a function of baseline fracture risk. Treatment with once-weekly teriparatide was associated with a statistically significant 79 % decrease in vertebral fractures, and in the cohort as a whole, efficacy was not related to baseline fracture risk.

introductionPrevious studies have suggested that the efficacy of some interventions may be greater in the segment of the population at highest fracture risk as assessed by the FRAX® algorithms. The aim of the present study was to determine whether the antifracture efficacy of weekly teriparatide was dependent on the magnitude of fracture risk.

methodsBaseline fracture probabilities (using FRAX) were computed from the primary data of a phase 3 study (TOWER) of the effects of weekly teriparatide in 542 men and postmenopausal women with osteoporosis. The outcome variable comprised morphometric vertebral fractures. Interactions between fracture probability and efficacy were explored by Poisson regression.

resultsThe 10-year probability of major osteoporotic fractures (without BMD) ranged from 7.2 to 42.2 %. FRAX-based hip fracture probabilities ranged from 0.9 to 29.3 %. Treatment with teriparatide was associated with a 79 % (95 % CI 52-91 %) decrease in vertebral fractures assessed by semiquantitative morphometry. Relative risk reductions for the effect of teriparatide on the fracture outcome did not change significantly across the range of fracture probabilities (p = 0.28). In a subgroup analysis of 346 (64 %) participants who had FRAX probabilities calculated with the inclusion of BMD, there was a small but significant interaction (p = 0.028) between efficacy and baseline fracture probability such that high fracture probabilities were associated with lower efficacy.

conclusionWeekly teriparatide significantly decreased the risk of morphometric vertebral fractures in men and postmenopausal women with osteoporosis. Overall, the efficacy of teriparatide was not dependent on the level of fracture risk assessed by FRAX in the cohort as a whole.

Indexed as

AgedAged, 80 and overAlgorithmsBone DensityBone Density Conservation AgentsDouble-Blind MethodDrug Administration ScheduleFemaleHip FracturesHumansMaleOsteoporosisOsteoporotic FracturesRisk AssessmentSpinal FracturesTeriparatideBone Density Conservation AgentsTeriparatide

Identifiers

PMID26092062
PMCPMC4532707
OpenAlexW1564047582

What OpenQuestion holds

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LicenceCC BY-NC
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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.