Evidence map›Paper›PMID 34849989›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2022

Denosumab After Teriparatide in Premenopausal Women With Idiopathic Osteoporosis.

Elizabeth Shane, Stephanie Shiau, Robert R Recker, Joan M Lappe, Sanchita Agarwal, Mafo Kamanda-Kosseh, Mariana Bucovsky, Julie Stubby, Adi Cohen

Open access · bronzeAbstract readClinical Trial, Phase II
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 28 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 4 pooled it
3.0field-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

28 citing papers in PubMed, 4 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Bone density and remodeling after discontinuation of sequential therapy for premenopausal idiopathic osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Trial
  6. Impact of standard versus cyclic teriparatide and denosumab treatment on trabecular bone score: a post-hoc analysis of a randomized clinical trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
    Trial
  7. Trial
  8. Article
  9. Postoperative osteoporosis therapy and risk of re-fracture in elderly patients with hip fractures: a multicenter retrospective cohort study.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
  10. Review
  11. Review
  12. Review
  13. Porous PLGA microspheres loaded with PTHJournal of orthopaedic translation · 2025
    Article
  14. Review
  15. The clinical trial landscape of anti-RANKL agents for osteoporosis: current status and future directions.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
    Article
  16. Article
  17. Effect of romosozumab on bone mineral density and trabecular bone score in premenopausal women with low bone mass.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
    Article
  18. Review
  19. Article
  20. 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

9 authors at 3 institutions in 1 country.

Elizabeth ShaneDepartment of Medicine, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.
Stephanie ShiauDepartment of Biostatistics and Epidemiology, Rutgers School of Public Health, Piscataway, NJ, USA.
Robert R ReckerDepartment of Medicine, Creighton University Medical Center, Omaha, NE, USA.
Joan M LappeDepartment of Medicine, Creighton University Medical Center, Omaha, NE, USA.
Sanchita AgarwalDepartment of Medicine, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, 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.
Julie StubbyDepartment of Medicine, Creighton University Medical Center, Omaha, NE, USA.
Adi CohenDepartment of Medicine, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.ORCID 0000-0002-0641-5747
Columbia University · USCHI Health Creighton University Medical Center - Bergan Mercy · USRutgers, The State University of New Jersey · 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
Bone Quality in Premenopausal Women with Idiopathic Fragility FracturesK23AR054127 · NIAMS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI COHEN, ADI · 2007 to 2011
$642k
IGF-1, bone turnover and response to teriparatide in premenopausal women with IOPR03AR064016 · NIAMS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI COHEN, ADI · 2013 to 2015
$244k
FDA HHS R01 FD003902NIAMS NIH HHS K23 AR054127NIAMS NIH HHS K24 AR052665NIAMS NIH HHS R03 AR064016
6 · The paper itself

Abstract

contextWe have previously reported that teriparatide is associated with substantial increases in bone mineral density (BMD) at the lumbar spine (LS), total hip (TH), and femoral neck (FN) and small declines at the distal radius in 41 premenopausal women with idiopathic osteoporosis (IOP), all severely affected with low trauma fractures and/or very low BMD. Effects of teriparatide dissipate if not followed by antiresorptives.

objectiveTo assess the effects of 12 and 24 months of denosumab in premenopausal women with IOP completing 24 months of teriparatide.

methodsThis was a preplanned phase 2B extension study. Premenopausal women with IOP who had completed a course of teriparatide received denosumab 60 mg every 6 months over 24 months. The main outcome measure was within-group change in BMD at the LS at 12 months. Secondary outcomes include change in 12-month BMD at other sites, 24-month BMD at all sites, trabecular bone score (TBS), and bone turnover markers (BTMs).

resultsAfter completing teriparatide, 32 participants took denosumab for 12 months and 29 for 24 months, with statistically significant increases in BMD at the LS (5.2 ± 2.6% and 6.9 ± 2.6%), TH (2.9 ± 2.4% and 4.6 ± 2.8%), and FN (3.0 ± 3.8% and 4.7 ± 4.9%). Over the entire 24-month teriparatide and 24-month denosumab treatment period, BMD increased by 21.9 ± 7.8% at the LS, 9.8 ± 4.6% at the TH, and 9.5 ± 4.7% at the FN (all P < .0001). TBS increased by 5.8 ± 5.6% (P < .001). Serum BTM decreased by 75% to 85% by 3 months and remained suppressed through 12 months of denosumab. Denosumab was generally well tolerated.

conclusionThese data support the use of sequential teriparatide and denosumab to increase BMD in premenopausal women with severe osteoporosis.

Indexed as

Bone Density Conservation AgentsOsteoporosisOsteoporosis, PostmenopausalBone DensityDenosumabFemaleHumansLumbar VertebraeTeriparatideBone Density Conservation AgentsDenosumabTeriparatidebone densitybone turnover markersdenosumabpremenopausal osteoporosisteriparatide

Identifiers

PMID34849989
PMCPMC9122662
OpenAlexW3216944744

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.