Evidence map›Paper›PMID 29462094›Full record

Trial reportMenopause (New York, N.Y.)2018

Effects of abaloparatide on bone mineral density and risk of fracture in postmenopausal women aged 80 years or older with osteoporosis.

Michael R McClung, Nicholas C Harvey, Lorraine A Fitzpatrick, Paul D Miller, Gary Hattersley, Yamei Wang, Felicia Cosman

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Menopause (New York, N.Y.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05346419 (Risedronate With High-dose Vitamin D Resolves Hyperparathyroidism and Hypovitaminosis D But Not Osteoporosis in Mexican Postmenopausal Patients), which is not on this map. Cited by 17 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 4 pooled it
4.0field-weighted citation impact, top 6% 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.

NCT05346419 nacompletednot on this mapstarted 2021, after this paper: background citation

Risedronate With High-dose Vitamin D Resolves Hyperparathyroidism and Hypovitaminosis D But Not Osteoporosis in Mexican Postmenopausal Patients

TypeinterventionalSponsorHospital Regional 1o de OctubreRan2021 to 2022Enrolled33ConditionsPostmenopausal Osteoporosis, Hypovitaminosis D, HyperparathyroidismArmsRisedronate, Vitamin D
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 4 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Review
  6. Review
  7. The Sequential Therapy in Osteoporosis.Indian journal of orthopaedics · 2023
    Review
  8. Hormones and Aging: An Endocrine Society Scientific Statement.The Journal of clinical endocrinology and metabolism · 2023
    Article
  9. Review
  10. Review
  11. Skeletal Aging.Mayo Clinic proceedings · 2022
    Review
  12. Review
  13. Article
  14. Review
  15. Abaloparatide and the Spine: A Narrative Review.Clinical interventions in aging · 2020
    Review
  16. Physiological roles of parathyroid hormone-related protein.Acta bio-medica : Atenei Parmensis · 2019
    Review
  17. Regulation of Skeletal Homeostasis.Endocrine reviews · 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

7 authors at 5 institutions in 3 countries.

Michael R McClungOregon Osteoporosis Center, Portland, OR.
Nicholas C HarveyMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, United Kingdom.
Lorraine A FitzpatrickRadius Health, Inc., Waltham, MA.
Paul D MillerColorado Center for Bone Research, Lakewood, CO.
Gary HattersleyRadius Health, Inc., Waltham, MA.
Yamei WangRadius Health, Inc., Waltham, MA.
Felicia CosmanHelen Hayes Hospital, West Haverstraw, NY.
Radius Health (United States) · USAustralian Catholic University · AUColorado Center for Bone Research · USColumbia University · USUniversity of Southampton · 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_12011/1Versus Arthritis 17702Versus Arthritis 21231
6 · The paper itself

Abstract

objectiveAdvanced age is an important risk factor for fracture. The Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) trial showed that subcutaneous abaloparatide increased bone mineral density (BMD) and reduced the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis. This study describes the effects of abaloparatide in the subgroup of women aged 80 or more years in ACTIVE.

methodsPost hoc analyses of BMD and fracture incidence in this subgroup of women who received abaloparatide or placebo in the 18-month, phase 3, double-blind, randomized controlled ACTIVE trial.

resultsThe mean ages of the women ≥80 years were 81.9 and 81.7 years in the placebo (n = 43) and abaloparatide (n = 51) groups, respectively. The increases in BMD from baseline to 18 months with abaloparatide treatment were 3.9% at the total hip (P < 0.001), 3.6% at the femoral neck (P < 0.01), and 12.1% at the lumbar spine (P < 0.001), and were similar to those observed in the overall population. Abaloparatide therapy was associated with numerical, but not statistically significant, reductions in the risk of vertebral and nonvertebral fractures in this subpopulation, compared with placebo. The proportion of participants reporting adverse events was similar between treatment groups and between the older subgroup and the overall population.

conclusionAbaloparatide was effective in increasing BMD in the very elderly subgroup of ACTIVE, with a safety profile similar to that of the overall study population.

Indexed as

Aged, 80 and overBone DensityBone Density Conservation AgentsDouble-Blind MethodFemaleFemur NeckHumansIncidenceLumbar VertebraeOsteoporosis, PostmenopausalOsteoporotic FracturesParathyroid Hormone-Related ProteinPelvic BonesPostmenopauseRisk FactorsSpinal FracturesabaloparatideBone Density Conservation AgentsParathyroid Hormone-Related Protein

Identifiers

PMID29462094
PMCPMC6015760
OpenAlexW2789499812

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.