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

NCT04742010 | Unknown Phase 2 DMC

• 1 other identifier: 20/41068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In a randomised placebo-controlled trial assess effects of zoledronic acid for prevention of bone and muscle loss after bariatric surgery.

Conditions

Bone Loss; Muscle Atrophy; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Quantitative Computed Tomography (QCT)

  Volumetric bone mineral density at the lumbar spine (L1 -L2) (Mindways QCT Pro software, Texas, USA).

  Change from baseline to 12 and 24 months after bariatric surgery

Secondary Outcomes (7)

• QCT

  Change from baseline to 12 and 24 months after bariatric surgery

• Biochemical calcium-metabolic markers

  Change from baseline to 12 and 24 months after bariatric surgery

• DEXA

  Change from baseline to 12 and 24 months after bariatric surgery

• HR-pQCT

  Change from baseline to 12 and 24 months after bariatric surgery

• Cortical bone stiffness

  Change from baseline to 12 and 24 months after bariatric surgery

Study Arms (2)

Zoledronic Acid

EXPERIMENTAL

Active treatment

Drug: Zoledronic Acid

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Zoledronic Acid DRUG

* A single treatment 21 days before bariatric surgery with Zoledronic acid 5 mg or placebo (an interval of 5 to 180 days is accepted) * Pharmaceutical form: Solution for infusion (100 ml normal saline containing 5 mg zoledronic acid or placebo) * Administration: slow intravenous infusion with a duration of at least 15 minutes

Zoledronic Acid

Placebo DRUG

as above

Placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Eligible for bariatric surgery (BMI\>35 kg/m2 with obesity-related comorbidity)

You may not qualify if:

• Pregnancy or breastfeeding.
• Chronic kidney disease with estimated GFR\<45 ml/min.
• Hypocalcemia .
• Hypersensitivity to bisphosphonates, mannitol, sodium citrate or water.
• Metabolic bone disease (osteoporosis is allowed).
• Prior treatment with anti-osteoporotic agents.
• Treatment with oral glucocorticoids
• Other diseases with known effects on bone metabolism

Sponsors & Collaborators

• Stinus Gadegaard Hansen: lead
• Research Unit of Health Sciences, Hospital of South West Jutland: collaborator
• Department of Regional Health Research, University of Southern Denmark: collaborator
• OPEN - Odense Patient data Explorative Network, The University of Southern Denmark, Odense, Denmark: collaborator
• Department of Radiology and Nuclear Medicine, Hospital of Southwest Jutland, 6700 Esbjerg, Denmark: collaborator
• Odense University Hospital: collaborator

Study Sites (1)

Hospital South West Jutland

Esbjerg, 6700, Denmark

RECRUITING

Related Publications (28)

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• Gam S, Hermann AP, Juhl CB, Hansen SG, Gram B. Effect of Zoledronic Acid on Skeletal Muscle After Bariatric Surgery: A Secondary Analysis From a Randomized Controlled Trial. Obesity (Silver Spring). 2026 Jan;34(1):76-87. doi: 10.1002/oby.70062. Epub 2025 Nov 2.

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• Gam S, Gram B, Juhl CB, Hermann AP, Hansen SG. Zoledronic Acid for prevention of bone and muscle loss after BAriatric Surgery (ZABAS)-a study protocol for a randomized controlled trial. Trials. 2022 Oct 8;23(1):861. doi: 10.1186/s13063-022-06766-z.

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MeSH Terms

Conditions

Bone Diseases, Metabolic; Muscular Atrophy

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Stinus Gadegaard Hansen, MD, PhD

CONTACT

+45 27594121; Stinus.Gadegaard.Hansen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Endocrinologist, Associate professor, PhD

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 5, 2021
• Study Start: February 20, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)