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NCT Number: NCT04742010

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

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

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Key information

Conditions

Bone Loss Atrophy Bariatric Surgery Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Muscle Atrophy Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital South West Jutland

Esbjerg, 6700, Denmark

About this study

In individuals with severe obesity, bariatric surgery effectively reduces body weight, improves obesity related diseases and lowers mortality. A loss of bone and muscle mass and an increase in bone fracture risk are however seen after surgery. In this study it is examined if treatment with zoledronic acid (a drug used to treat osteoporosis) can prevent the bone and muscle loss after bariatric surgery. A single infusion of zoledronic acid or placebo is given before surgery. The study is blinded and randomized for methodological reasons. Bone and muscle scans, tests of muscle strength and physical performance and blood samples (for analysis of markers related to bone and muscle metabolism) are performed at inclusion and 12 and 24 months after surgery. A total of 60 adult individuals will participate. Results will be important for the evidence-based care of patients undergoing bariatric surgery and zoledronic acid.

Study design This is a single center randomized double-blind placebo-controlled study of zoledronic acid for prevention of bone and muscle loss after bariatric surgery. Routine bariatric surgery (RYGB or gastric sleeve) will be performed. The end of study is 24 months after surgery.

Study Population Patients referred for bariatric surgery at The Hospital South West Jutland, Esbjerg will be invited to participate.

Randomization After inclusion and baseline assessment, patients will be randomly assigned to either zoledronic acid or placebo with a 1:1 allocation. A randomization code stratifying an equal number of participants having RYGB or SG into each study arm will be applied.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Placebo

Drug

as above

Primary outcomes

  1. Quantitative Computed Tomography (QCT)

    Time frame: Change from baseline to 12 and 24 months after bariatric surgery

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

Secondary outcomes

  1. QCT

    Time frame: Change from baseline to 12 and 24 months after bariatric surgery

    Volumetric BMD at the proximal femur (Mindways QCT Pro software, Texas, USA).

  2. Biochemical calcium-metabolic markers

    Time frame: Change from baseline to 12 and 24 months after bariatric surgery

    Calcium, parathyroid hormone, vitamin D and markers of bone remodeling (CTX, P1NP).

  3. DEXA

    Time frame: Change from baseline to 12 and 24 months after bariatric surgery

    Bone mineral density at the lumbar spine and total hip (Hologic Discovery, Waltham, MA, US).

  4. HR-pQCT

    Time frame: Change from baseline to 12 and 24 months after bariatric surgery

    Radius and tibia bone microarchitecture (Scanco Medical AG, Brutisellen, Switzerland).

  5. Cortical bone stiffness

    Time frame: Change from baseline to 12 and 24 months after bariatric surgery

    Cortical bone material strength index (BMSi) assessed using microindentation at the anterior surface of the mid-tibia diaphysis (OsteoProbe, Active Life Scientific, California, US).

  6. Muscle Strength

    Time frame: Change from baseline to 12 and 24 months after bariatric surgery

    Upper and lower limb muscle strength assessed using dynamometers (foot, knee, shoulder, hand)

  7. Physical function

    Time frame: Change from baseline to 12 and 24 months after bariatric surgery

    Short physical performance battery (SPPB), Stair Climb, 2 minute walking test

Sponsors and collaborators

Lead sponsor

Stinus Gadegaard Hansen

Other

Collaborators

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

Registry information

Acronym: ZABAS

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 5, 2021
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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