Evidence map›Paper›PMID 36735054›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 USA2023

Loss of lower extremity bone mineral density 1 year after denosumab is discontinued in persons with subacute spinal cord injury.

Christopher M Cirnigliaro, Michael F La Fountaine, J Scott Parrott, Steven C Kirshblum, Susan J Sauer, Sue A Shapses, Isa A McClure, William A Bauman

Abstract readRandomized Controlled Trial
PubMed Publisher
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, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.2field-weighted citation impact, top 13% 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

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Review
  3. International Spinal Cord Injury Fracture History Extended Data Set.Topics in spinal cord injury rehabilitation · 2025
    Article
  4. Article
  5. Article
  6. 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

8 authors at 5 institutions in 1 country.

Christopher M CirnigliaroDepartment of Veterans Affairs Rehabilitation Research and Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, 130 West Kingsbridge Road, Bronx, NY, 10468, USA. christopher.cirnigliaro@gmail.com.ORCID http://orcid.org/0000-0003-1929-5067
Michael F La FountaineDepartment of Veterans Affairs Rehabilitation Research and Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, 130 West Kingsbridge Road, Bronx, NY, 10468, USA.
J Scott ParrottDepartment of Interdisciplinary Studies, School of Health Professions, Rutgers Biomedical and Health Sciences, Newark, NJ, USA.
Steven C KirshblumKessler Institute for Rehabilitation, West Orange, NJ, USA.
Susan J SauerKessler Institute for Rehabilitation, West Orange, NJ, USA.
Sue A ShapsesDepartment of Nutritional Sciences, Rutgers University, New Brunswick, NJ, USA.
Isa A McClureDP Clinical, Inc, Rockville, MD, USA.
William A BaumanDepartments of Medicine and Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Rutgers, The State University of New Jersey · USIcahn School of Medicine at Mount Sinai · USKessler Institute for Rehabilitation · USRehabilitation Research and Development Service · USSeton Hall University · US

Funding

Craig H. Neilsen Foundation 297267
6 · The paper itself

Abstract

Twelve months following discontinuation of denosumab, the percent decrease in mean bone mineral density (BMD) values at the hip and knee regions were similar between both the denosumab and placebo groups. These findings emphasize the need for additional trials to understand the effect of continued administration of denosumab after subacute spinal cord injury (SCI) to avoid this demineralization.

objectiveTo determine changes in BMD 1 year after denosumab was discontinued in participants with subacute SCI who had drug treatment initiated within 90 days post SCI and continued for 1 year.

methodsFourteen participants who completed a randomized, double-blinded, placebo-controlled drug trial (parent study: denosumab 60 mg (Prolia, Amgen Inc., n = 8) or placebo (n = 6); administered at baseline, 6, and 12 months) were followed 12 months after the 18 months from baseline primary end point was completed. The BMD of skeletal regions below the SCI at higher risk of fracture was measured [total hip, distal femur epiphysis (DFE), distal femur metaphysis (DFM), and proximal tibia epiphysis (PTE)] by dual energy X-ray absorptiometry.

resultsThe percent decreases in mean BMD values at all regions of the hip and knee from 18 to 30 months were similar in both the denosumab and placebo groups. However, at 30 months, the absolute values for mean BMD remained significantly higher in the drug treatment than that of the placebo group at the DFM (p = 0.03), DFE (p = 0.04), and PTE (p = 0.05).

conclusionsIn persons with SCI who initiated denosumab treatment during the subacute injury phase and maintained treatment for 1 year, the discontinuation of drug resulted in percent loss of mean BMD similar to that of the placebo group, with absolute mean BMD values at the knee regions at the 12-month follow-up visit significantly higher in the drug treatment than those in the placebo group. These data underscore the need to study continued administration of denosumab after subacute SCI to avoid marked demineralization in the sublesional skeleton upon discontinuation of this agent.

Indexed as

Bone Density Conservation AgentsBone Diseases, MetabolicSpinal Cord InjuriesBone DensityDenosumabHumansLower ExtremityBone Density Conservation AgentsDenosumabBone mineral densityDenosumab discontinuationDual energy x-ray absorptiometryImmobilization osteoporosisSpinal cord injury

Identifiers

PMID36735054
OpenAlexW4319058777

What OpenQuestion holds

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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.