Evidence map›Paper›PMID 36209245›Full record

ArticleTrials2022

Zoledronic Acid for prevention of bone and muscle loss after BAriatric Surgery (ZABAS)-a study protocol for a randomized controlled trial.

Søren Gam, Bibi Gram, Claus Bogh Juhl, Anne Pernille Hermann, Stinus Gadegaard Hansen

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

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04742010 (Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.3field-weighted citation impact, top 20% 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.

NCT04742010 phase2completednot on this map

Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)

TypeinterventionalSponsorStinus Gadegaard HansenRan2021 to 2024Enrolled59ConditionsBone Loss, Muscle Atrophy, Bariatric SurgeryArmsZoledronic Acid, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Observational
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

5 authors at 3 institutions in 1 country.

Søren GamDepartment of Medicine, University Hospital of Southern Denmark, Odense, Denmark. sorengam1987@gmail.com.ORCID http://orcid.org/0000-0002-2461-2824
Bibi GramThe Research Unit of Health Sciences, University Hospital of Southern Denmark, Odense, Denmark.
Claus Bogh JuhlDepartment of Medicine, University Hospital of Southern Denmark, Odense, Denmark.
Anne Pernille HermannDepartment of Endocrinology, Odense University Hospital, Odense, Denmark.
Stinus Gadegaard HansenDepartment of Medicine, University Hospital of Southern Denmark, Odense, Denmark.
Steno Diabetes Centers · DKUniversity of Southern Denmark · DKOdense University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBariatric surgery has adverse effects on the muscular-skeletal system with loss of bone mass and muscle mass and an increase in the risk of fracture. Zoledronic acid is widely used in osteoporosis and prevents bone loss and fracture. Bisphosphonates may also have positive effects on skeletal muscle. The aim of this study is to investigate the effects of zoledronic acid for the prevention of bone and muscle loss after bariatric surgery.  METHODS/

designThis is a randomized double-blind placebo-controlled study. Sixty women and men with obesity aged 35 years or older will complete baseline assessments before randomization to either zoledronic acid (5 mg in 100 ml isotonic saline) or placebo (100 ml isotonic saline only) 3 weeks before surgery with Roux-en-Y-gastric bypass (RYGB) or sleeve gastrectomy (SG). Follow-up assessments are performed 12 and 24 months after surgery. The primary outcome is changes in lumbar spine volumetric bone mineral density (vBMD) assessed by quantitative computed tomography (QCT). Secondary bone outcomes are changes in proximal femur vBMD assessed by QCT. Changes in cortical and trabecular bone microarchitecture and estimated bone strength will be assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT). Cortical material bone strength at the mid-tibia diaphysis will be assessed using microindentation and fasting blood samples will be obtained to assess biochemical markers of bone turnover and calcium metabolism.  Secondary muscle outcomes include whole body lean mass assessed using dual-energy X-ray absorptiometry. Dynamometers will be used to assess handgrip, shoulder, ankle, and knee muscle strength. Short Physical Performance Battery, 7.6-m walking tests, 2-min walking test, and a stair climb test will be assessed as biomarkers of physical function. Self-reported physical activity level is assessed using International Physical Activity Questionnaire (IPAQ). DISCUSSION: Results from this study will be instrumental for the evidence-based care of patients undergoing bariatric surgery.

trial registrationClinicalTrials.gov NCT04742010. Registered on 5 February 2021.

Indexed as

Bariatric SurgeryFractures, BoneAbsorptiometry, PhotonBiomarkersBone DensityCalciumFemaleHand StrengthHumansLumbar VertebraeMaleMusclesRandomized Controlled Trials as TopicZoledronic AcidBiomarkersCalciumZoledronic AcidBariatric surgeryBone lossBone microarchitectureGastric bypassLean body massMuscle lossMuscle mechanical functionSleeve gastrectomyVolumetric bone densityZoledronic Acid

Identifiers

PMID36209245
PMCPMC9548152
OpenAlexW4303672008

What Socratic holds

Textmetadata
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 Socratic graph.