Evidence map›Paper›PMID 34887285›Full record

ArticleBMJ open2021

Protocol for a pilot randomised controlled trial of zoledronic acid to prevent bone loss following sleeve gastrectomy surgery.

Laura E Flores, Lynn Mack, Christopher Wichman, Ashley A Weaver, Vishal Kothari, Laura D Bilek

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04279392 (Feasibility of Bisphosphonate Use on Sleeve Gastrectomy Associated Bone Loss), 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, top 71% 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.

NCT04279392 phase1 / phase2completednot on this map

Feasibility of Bisphosphonate Use on Sleeve Gastrectomy Associated Bone Loss: Healthy Body, Healthy Bones Trial

TypeinterventionalSponsorUniversity of NebraskaRan2020 to 2022Enrolled10ConditionsBariatric Surgery Candidate, Bone Loss, Bone ResorptionArmsZoledronic Acid 5 mg/Bag 100 ml Inj, Placebos
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Article
  2. 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

6 authors at 2 institutions in 1 country.

Laura E FloresCollege of Allied Health Professions, University of Nebraska Medical Center, Omaha, Nebraska, USA laura.flores@unmc.edu.ORCID 0000-0002-7861-5713
Lynn MackDiabetes, Endocrinology, & Metabolism, University of Nebraska Medical Center, Omaha, Nebraska, USA.
Christopher WichmanDepartment of Biostatistics, University of Nebraska Medical Center, Omaha, Nebraska, USA.
Ashley A WeaverDepartment of Biomedical Engineering, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Vishal KothariDepartment of Minimally Invasive Surgery, University of Nebraska Medical Center, Omaha, Nebraska, USA.
Laura D BilekCollege of Allied Health Professions, University of Nebraska Medical Center, Omaha, Nebraska, USA.
University of Nebraska Medical Center · USWake Forest University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSleeve gastrectomy (SG) is an increasingly used and effective treatment for obesity; however, the rapid weight loss associated with SG adversely affects bone metabolism predisposing patients to skeletal fragility. Bisphosphonate medications have been evaluated for safety and efficacy in combating bone loss in patients with osteoporosis, but their use in SG-induced bone loss is limited. The goal of this study is to investigate how a one-time infusion of zoledronic acid compares to placebo, in its ability to combat SG-associated bone loss. METHODS AND ANALYSIS: This research protocol is a 9-month, pilot randomized controlled trial (RCT) involving 30 adult SG patients randomised to receive an infusion of either 5 mg of zoledronic acid or placebo, 6 weeks following surgery. To be included participants must be <350 lbs/158.8 kg, free of bone-impacting pathologies or medications, and must have adequate serum calcium and vitamin D levels at baseline. The primary outcome is change in areal bone mineral density (aBMD) at the total hip. Secondary outcomes include change in aBMD of the femoral neck, and lumbar spine, and change in volumetric BMD at the lumbar spine. The primary aim will be tested using a linear mixed model fit with total hip aBMD at 9 months as the outcome. Treatment, participant sex and menopausal status will be considered in analysis. Groups will be compared using contrast statements at 9 months, with change over 9 months being the primary comparison. ETHICS AND DISSEMINATION: This study was approved by the Institutional Review Board of the University of Nebraska Medical Center (IRB820-19). Written consent will be obtained from participants at enrolment by trained staff. Careful and thorough explanation are used in obtainment of consent and voluntariness is emphasised throughout the trial. The findings of this study will be presented locally, nationally, and published in peer-reviewed journals. Additional details will be reported on ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: NCT04279392.

Indexed as

Bone DensityGastrectomyAdultFemur NeckHumansPilot ProjectsRandomized Controlled Trials as TopicZoledronic AcidZoledronic Acidadult gastroenterologycalcium & bonegeneral endocrinologymalabsorption

Identifiers

PMID34887285
PMCPMC8663101
OpenAlexW4200134496

What OpenQuestion holds

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LicenceCC BY-NC
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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.