Evidence map›Paper›PMID 39854280›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2025

Romosozumab Improves Tissue Thickness-Adjusted Trabecular Bone Score in Women With Osteoporosis and Diabetes.

Serge Ferrari, Donald Betah, Robert G Feldman, Bente L Langdahl, Mary Oates, Jen Timoshanko, Zhenxun Wang, Ruban Dhaliwal

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01631214 (A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT01631214 phase3completednot on this map

A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

TypeinterventionalSponsorAmgenRan2012 to 2017Enrolled4,093ConditionsPostmenopausal Women With OsteoporosisArmsRomosozumab, Alendronate, Placebo to Romosozumab, Placebo to Alendronate
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Influence of bisphosphonate pretreatment on bone mineral density gains and fracture outcomes with teriparatide: A systematic review and meta-analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Review
  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

8 authors.

Serge FerrariGeneva University Hospital, Geneva 1211, Switzerland.ORCID 0000-0002-1372-4417
Donald BetahAmgen Inc., Thousand Oaks, CA 91320, USA.
Robert G FeldmanMemorialCare Saddleback Medical Center, Laguna Hills, CA 92653, USA.
Bente L LangdahlAarhus University Hospital and Aarhus University, 8200 Aarhus, Denmark.
Mary OatesAmgen Inc., Thousand Oaks, CA 91320, USA.
Jen TimoshankoUCB, Slough SL1 3WE, UK.
Zhenxun WangAmgen Inc., Thousand Oaks, CA 91320, USA.ORCID 0000-0002-1636-7240
Ruban DhaliwalThe University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.

Funding

AmgenAstellas Pharma Inc
6 · The paper itself

Abstract

contextTrabecular bone score (TBS), a gray-level texture index derived from lumbar spine (LS) dual-energy x-ray absorptiometry (DXA) scans, is decreased in patients with diabetes and is associated with increased fracture risk, independent of areal bone mineral density (aBMD), but potentially influenced by abdominal fat tissue.

objectiveEvaluate effect of romosozumab (210 mg monthly) for 12 months followed by alendronate (70 mg weekly) for 24 months vs alendronate alone (70 mg weekly) for 36 months on LS aBMD and TBS in women with type 2 diabetes (T2D) enrolled in the ARCH study.

methodsThis post hoc analysis included women from ARCH who had T2D at baseline and LS DXA scans at baseline and ≥1 postbaseline visit (romosozumab-to-alendronate, n = 165; alendronate-to-alendronate, n = 195). aBMD and TBS (determined by an updated tissue thickness-adjusted TBS algorithm [TBSTT]) were assessed on LS DXA scans at baseline and ≥1 postbaseline visit (months 12, 24, and 36).

resultsRomosozumab led to significantly greater gains in LS aBMD and TBSTT at month 12 vs alendronate, and the greater gains with romosozumab were maintained after transition to alendronate and persisted significantly at months 24 and 36 vs alendronate alone. TBSTT percentage changes weakly correlated to LS aBMD percentage changes from baseline to month 36 (romosozumab-to-alendronate, R2 = 0.1493; alendronate-to-alendronate, R2 = 0.0429).

conclusionIn postmenopausal women with osteoporosis and T2D, 12 months of romosozumab followed by 24 months of alendronate vs alendronate alone significantly improved LS aBMD and TBSTT (independently of abdominal fat) and to a greater extent. Hence, romosozumab may improve bone strength in patients with T2D.

trial registrationClinicalTrials.gov-NCT01631214.

Indexed as

Antibodies, MonoclonalBone DensityBone Density Conservation AgentsCancellous BoneDiabetes Mellitus, Type 2Osteoporosis, PostmenopausalAbsorptiometry, PhotonAgedAlendronateDrug Therapy, CombinationFemaleHumansLumbar VertebraeMiddle AgedAlendronateAntibodies, MonoclonalBone Density Conservation Agentsromosozumabanabolicbone mineral densityDXAfracture riskosteoporosistype 2 diabetes (T2D)

Identifiers

PMID39854280
PMCPMC12448627

What OpenQuestion holds

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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.