Evidence map›Paper›PMID 28474780›Full record

Trial reportJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2017

The Effect of Abaloparatide-SC on Fracture Risk Is Independent of Baseline FRAX Fracture Probability: A Post Hoc Analysis of the ACTIVE Study.

Eugene V McCloskey, Helena Johansson, Anders Oden, Nicholas C Harvey, Hai Jiang, Sara Modin, Lorraine Fitzpatrick, John A Kanis

Open access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
6.6field-weighted citation impact, top 3% 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

24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. 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
  5. 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
  6. Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2019
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Efficacy of teriparatide compared with risedronate on FRAXOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2020
    Article
  16. Osteoanabolic and dual action drugs.British journal of clinical pharmacology · 2019
    Review
  17. Article
  18. 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
  19. Article
  20. A brief history of FRAX.Archives of osteoporosis · 2018
    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

8 authors at 5 institutions in 4 countries.

Eugene V McCloskeyCentre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK.
Helena JohanssonCentre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK.
Anders OdenCentre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK.
Nicholas C HarveyMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.
Hai JiangRadius Health, Inc., Waltham, MA, USA.
Sara ModinRadius Health, Inc., Waltham, MA, USA.
Lorraine FitzpatrickRadius Health, Inc., Waltham, MA, USA.
John A KanisCentre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK.
Radius Health (United States) · USUniversity of Sheffield · GBAustralian Catholic University · AUMRC Lifecourse Epidemiology Unit · GBVersus Arthritis · GB

Funding

Arthritis Research UK 17702Arthritis Research UK 21231Department 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_12011/1
6 · The paper itself

Abstract

Daily subcutaneous (SC) injections of the investigational drug abaloparatide-SC (80 mcg) for 18 months significantly decrease the risk of vertebral and nonvertebral fracture compared with placebo in postmenopausal women. We examined the efficacy of abaloparatide-SC as a function of baseline fracture risk, assessed using the FRAX tool. Baseline clinical risk factors (age, body mass index [BMI], prior fracture, glucocorticoid use, rheumatoid arthritis, and smoking) were entered into country-specific FRAX models to calculate the 10-year probability of major osteoporotic fractures, with or without femoral neck bone mineral density (BMD). The interaction between probability of a major osteoporotic fracture and treatment efficacy was examined by a Poisson regression. A total of 821 women randomized to placebo and 824 women to abaloparatide-SC, mean age 69 years in both groups, were followed for up to 2 years. At baseline, the 10-year probability of major osteoporotic fractures (with BMD) ranged from 2.3% to 57.5% (mean 13.2%). Treatment with abaloparatide-SC was associated with a 69% (95% confidence interval [CI] 38-85%) decrease in major osteoporotic fracture (MOF) and a 43% (95% CI 9-64%) decrease in any clinical fracture compared with placebo. For all outcomes, hazard ratios tended to decrease (ie, greater efficacy) with increasing fracture probability. Whereas the interaction approached significance for the outcome of any fracture (p = 0.11), there was no statistically significant interaction for any of the fracture outcomes. Similar results were noted when FRAX probability was computed without BMD. Efficacy of abaloparatide-SC to decrease the risk of major osteoporotic fracture or any clinical fracture in postmenopausal women with low BMD and/or prior fracture appears independent of baseline fracture probability. © 2017 American Society for Bone and Mineral Research.

Indexed as

Body Mass IndexAgedAged, 80 and overAge FactorsBone DensityDouble-Blind MethodFemaleFemoral Neck FracturesFemur NeckHumansMiddle AgedOsteoporosis, PostmenopausalParathyroid Hormone-Related ProteinRisk FactorsabaloparatideParathyroid Hormone-Related ProteinABALOPARATIDE-SCFRACTURE RISKFRAXOSTEOPOROSIS

Identifiers

PMID28474780
PMCPMC5553106
OpenAlexW2611457288

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.