Evidence map›Paper›PMID 32623487›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2020

A single dose of zoledronate preserves bone mineral density for up to 2 years after a second course of romosozumab.

M R McClung, M A Bolognese, J P Brown, J-Y Reginster, B L Langdahl, J Maddox, Y Shi, M Rojeski, P D Meisner, A Grauer

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

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00896532 (A Randomised, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women With Low Bone Mineral Density), which is not on this map. Cited by 28 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 5 pooled it
2.2field-weighted citation impact, top 10% 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.

NCT00896532 phase2completednot on this map

A Randomised, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women With Low Bone Mineral Density

TypeinterventionalSponsorAmgenRan2009 to 2016Enrolled419ConditionsLow Bone Mineral Density, Postmenopausal OsteoporosisArmsPlacebo to Romosozumab, Alendronate, Teriparatide, Romosozumab, Denosumab
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 5 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. A systematic review and meta-analysis of sequential treatment strategies for 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
    Pooled it
  2. Romosozumab for the treatment of osteoporosis - a systematic review.Journal of endocrinological investigation · 2025
    Pooled it
  3. Pooled it
  4. Guideline
  5. Pooled it
  6. Efficacy of sequential romosozumab-denosumab therapy in patients on hemodialysis: association with bone mineral density improvement and TRACP-5b rebound.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
  7. Review
  8. Review
  9. Clarifying clinically treatment-naive status for osteoporosis patients.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
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Management of bone loss due to endocrine therapy during cancer treatment.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2023
    Review
  18. Review
  19. Article
  20. 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

10 authors at 6 institutions in 6 countries.

M R McClungOregon Osteoporosis Center, 2881 NW Cumberland Road, Portland, OR 97210, USA. mmcclung.ooc@gmail.com.
M A BologneseBethesda Health Research Center, Bethesda, MD, USA.
J P BrownLaval University and CHU de Québec (CHUL) Research Centre, Québec City, QC, Canada.
J-Y ReginsterUniversity of Liège, Liège, Belgium.
B L LangdahlAarhus University Hospital, Aarhus, Denmark.
J MaddoxAmgen Inc., Thousand Oaks, CA, USA.
Y ShiAmgen Inc., Thousand Oaks, CA, USA.
M RojeskiAmgen Inc., Thousand Oaks, CA, USA.
P D MeisnerUCB Pharma, Brussels, Belgium.
A GrauerAmgen Inc., Thousand Oaks, CA, USA.
Amgen (United States) · USAarhus University Hospital · DKAustralian Catholic University · AUUCB Pharma (Belgium) · BEUniversité Laval · CAUniversity of Liège · BE

Funding

Amgen Inc. Not applicableAstellas Not applicableUCB Pharma Not applicable
6 · The paper itself

Abstract

This phase 2 study evaluated the efficacy and safety of transitioning to zoledronate following romosozumab treatment in postmenopausal women with low bone mass. A single dose of 5 mg zoledronate generally maintained the robust BMD gains accrued with romosozumab treatment and was well tolerated.

introductionFollow-on therapy with an antiresorptive agent is necessary to maintain the skeletal benefits of romosozumab therapy. We evaluated the use of zoledronate following romosozumab treatment.

methodsThis phase 2, dose-finding study enrolled postmenopausal women with low bone mineral density (BMD). Subjects who received various romosozumab doses or placebo from months 0-24 were rerandomized to denosumab (60 mg SC Q6M) or placebo for 12 months, followed by open-label romosozumab (210 mg QM) for 12 months. At month 48, subjects who had received active treatment for 48 months were assigned to no further active treatment and all other subjects were assigned to zoledronate 5 mg IV. Efficacy (BMD, P1NP, and β-CTX) and safety were evaluated for 24 months, up to month 72.

resultsA total of 141 subjects entered the month 48-72 period, with 51 in the no further active treatment group and 90 in the zoledronate group. In subjects receiving no further active treatment, lumbar spine (LS) BMD decreased by 10.8% from months 48-72 but remained 4.2% above the original baseline. In subjects receiving zoledronate, LS BMD was maintained (percentage changes: - 0.8% from months 48-72; 12.8% from months 0-72). Similar patterns were observed for proximal femur BMD in both groups. With no further active treatment, P1NP and β-CTX decreased but remained above baseline at month 72. Following zoledronate, P1NP and β-CTX levels initially decreased but approached baseline by month 72. No new safety signals were observed.

conclusionA zoledronate follow-on regimen can maintain robust BMD gains achieved with romosozumab treatment.

Indexed as

Antibodies, MonoclonalBone Density Conservation AgentsOsteoporosis, PostmenopausalZoledronic AcidAgedBone DensityFemaleHumansMiddle AgedAntibodies, MonoclonalBone Density Conservation AgentsromosozumabZoledronic AcidAntiresorptiveBone mineral densityFollow-on regimenOsteoporosisRomosozumab

Identifiers

PMID32623487
PMCPMC7560921
OpenAlexW3038789783

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.