Evidence map›Paper›PMID 37456507›Full record

ArticleContemporary clinical trials communications2023

Strategies to reduce the onset of sleeve gastrectomy associated bone loss (STRONG BONES): Trial design and methods.

Joshua R Stapleton, Jamy D Ard, Daniel P Beavers, Lori S Cogdill, Adolfo Z Fernandez, Marjorie J Howard, Jamie N Justice, S Delanie Lynch, Jovita J Newman, Ashley A Weaver and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04922333 (Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 30% 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.

NCT04922333 phase3recruitingnot on this map

Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

TypeinterventionalSponsorWake Forest University Health SciencesRan2023 to 2028Enrolled200ConditionsBone LossArmsRisedronate, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Trial
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

11 authors at 2 institutions in 1 country.

Joshua R StapletonDepartment of Biomedical Engineering, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Jamy D ArdWeight Management Center, Atrium Health Wake Forest Baptist, Winston-Salem, NC, USA.
Daniel P BeaversDepartment of Statistical Sciences, Wake Forest University, Winston-Salem, NC, USA.
Lori S CogdillDepartment of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA.
Adolfo Z FernandezWeight Management Center, Atrium Health Wake Forest Baptist, Winston-Salem, NC, USA.
Marjorie J HowardDepartment of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Jamie N JusticeDepartment of Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
S Delanie LynchDepartment of Biomedical Engineering, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Jovita J NewmanDepartment of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA.
Ashley A WeaverDepartment of Biomedical Engineering, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Kristen M BeaversDepartment of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA.
Wake Forest University · USAtrium Health Wake Forest Baptist · US

Funding

Wake Forest Claude D. Pepper OAIC - RenewalP30AG021332 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI LEON LENCHIK · 2002 to 2026
$36.4M
Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric SurgeryU01AR080969 · NIAMS · WAKE FOREST UNIVERSITY · PI Jamy D Ard, Kristen Marie Beavers · 2022 to 2026
$2.5M
NIAMS NIH HHS U01 AR080969NIA NIH HHS P30 AG021332
6 · The paper itself

Abstract

Background: Despite recognized improvements in obesity-related comorbidities, mounting evidence implicates surgical weight loss in the onset of skeletal fragility. Sleeve gastrectomy (SG) is the most commonly performed bariatric procedure and is associated with 3-7% axial bone loss in the year following surgery. Bisphosphonates are FDA-approved medications for the prevention and treatment of age-related bone loss and may represent a strategy to reduce bone loss following SG surgery. Methods: The Strategies to Reduce the Onset of Sleeve Gastrectomy Associated Bone Loss (STRONG BONES) trial (NCT04922333) is designed to definitively test whether monthly administration of the bisphosphonate, risedronate, for six months can effectively counter SG-associated bone loss. Approximately 120 middle-aged and older (≥40 years) SG patients will be randomized to six months of risedronate or placebo treatment, with skeletal outcomes assessed at baseline, six, and 12-months post-surgery. The primary outcome of the trial is 12-month change in total hip areal bone mineral density (aBMD), measured by dual energy x-ray absorptiometry (DXA). This will be complemented by DXA-acquired aBMD assessment at other skeletal sites and quantitative computed tomography (QCT) derived changes in bone quality. Change in muscle mass and function will also be assessed, as well as biomarkers of bone health, turnover, and crosstalk, providing mechanistic insight into intervention-related changes to the bone-muscle unit. Discussion: Results from the STRONG BONES trial have the potential to influence current clinical practice by determining the ability of bisphosphonate use to mitigate bone loss and concomitant fracture risk in middle-aged and older SG patients.

Indexed as

Bariatric surgeryBisphosphonateBone mineral densityOlder adultsWeight loss

Identifiers

PMID37456507
PMCPMC10344650
OpenAlexW4382934575

What OpenQuestion holds

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LicenceCC BY
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.