Evidence map›Paper›PMID 35428889›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2022

Spine Volumetric BMD and Strength in Premenopausal Idiopathic Osteoporosis: Effect of Teriparatide Followed by Denosumab.

Sanchita Agarwal, Elizabeth Shane, Thomas Lang, Stephanie Shiau, Mafo Kamanda-Kosseh, Mariana Bucovsky, Joan M Lappe, Julie Stubby, Robert R Recker, Yizhong Hu and 3 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.7field-weighted citation impact, top 19% 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

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. 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

13 authors at 4 institutions in 1 country.

Sanchita AgarwalDepartment of Medicine, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.ORCID 0000-0003-4978-0717
Elizabeth ShaneDepartment of Medicine, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.
Thomas LangDepartment of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, CA, USA.
Stephanie ShiauDepartment of Biostatistics & Epidemiology, Rutgers School of Public Health, Piscataway, NJ, USA.
Mafo Kamanda-KossehDepartment of Medicine, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.
Mariana BucovskyDepartment of Medicine, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.
Joan M LappeDepartment of Medicine, Creighton University Medical Center, Omaha, NE, USA.
Julie StubbyDepartment of Medicine, Creighton University Medical Center, Omaha, NE, USA.
Robert R ReckerDepartment of Medicine, Creighton University Medical Center, Omaha, NE, USA.
Yizhong HuBone Bioengineering Laboratory, Department of Biomedical Engineering, Columbia University, New York, NY, USA.
Zexi WangBone Bioengineering Laboratory, Department of Biomedical Engineering, Columbia University, New York, NY, USA.
X Edward GuoBone Bioengineering Laboratory, Department of Biomedical Engineering, Columbia University, New York, NY, USA.
Adi CohenDepartment of Medicine, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.
Columbia University · USCHI Health Creighton University Medical Center - Bergan Mercy · USRutgers, The State University of New Jersey · USUniversity of California, San Francisco · US

Funding

Teriparatide for Idiopathic Osteoporosis in Premenopausal Women: A Phase 2 StudyR01FD003902 · FDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI COHEN, ADI, SHANE, ELIZABETH J · 2011 to 2019
$2.8M
Idiopathic Osteoporosis in Premenopausal WomenK24AR052665 · NIAMS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI SHANE, ELIZABETH J · 2005 to 2014
$1.8M
Phase 2b Study of Denosumab to Prevent Bone Loss in Idiopathic Osteoporosis in Premenopausal Women Treated with TeriparatideR01FD005114 · FDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI SHANE, ELIZABETH J · 2016 to 2019
$1.6M
FDA HHS R01 FD003902FDA HHS R01 FD005114NIAMS NIH HHS K24 AR052665
6 · The paper itself

Abstract

contextPremenopausal women with idiopathic osteoporosis (PreMenIOP) have marked deficits in bone density, microstructure, and strength.

objectiveTo define effects of treatment with teriparatide followed by denosumab on lumbar spine (LS) volumetric bone mineral density (vBMD) and stiffness by finite element analysis assessed on central quantitative computed tomography (cQCT) scans. DESIGN, SETTINGS, AND

participantsAncillary analysis of baseline, post-teriparatide, and post-denosumab cQCT scans from a randomized trial of 41 women allocated to teriparatide (20 mcg daily; n = 28) or placebo (n = 11). After 6 months, those on teriparatide continued for 18 months, and those on placebo switched to teriparatide for 24 months. After completing teriparatide, 33 enrolled in a Phase 2B extension with denosumab (60 mg every 6 months) for 12 months.

main outcome measuresPrimary outcomes were percentage change from baseline in LS trabecular vBMD and stiffness after teriparatide and between end of teriparatide and completing denosumab. Percentage change from baseline in LS trabecular vBMD and stiffness after sequential teriparatide and denosumab were secondary outcomes.

findingsThere were large increases (all Ps < 0.001) in trabecular vBMD (25%), other vBMD parameters, and stiffness (21%) after teriparatide. Statistically significant increases in trabecular vBMD (10%; P < 0.001) and other vBMD parameters (P = 0.03-0.001) were seen after denosumab, while stiffness increased by 7% (P = 0.068). Sequential teriparatide and denosumab led to highly significant (all Ps < 0.001) increases LS trabecular vBMD (43%), other vBMD parameters (15-31%), and stiffness (21%).

conclusionsThe large and statistically significant increases in volumetric density and stiffness after sequential treatment with teriparatide followed by denosumab are encouraging and support use of this regimen in PreMenIOP.

Indexed as

Bone Density Conservation AgentsOsteoporosisOsteoporosis, PostmenopausalBone DensityDenosumabFemaleHumansLumbar VertebraeTeriparatideBone Density Conservation AgentsDenosumabTeriparatidecentral QCTdenosumabpremenopausal osteoporosisstiffnessteriparatidevolumetric BMD

Identifiers

PMID35428889
PMCPMC9391607
OpenAlexW4223932572

What OpenQuestion holds

Textmetadata
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.