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Bone LossPhase 2ZABASNCT04742010

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

A Phase 2 study testing Zoledronic Acid in people with Bone Loss and Muscle Atrophy, run by Stinus Gadegaard Hansen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 35 years and older
Conditions the study is for
Bone Loss, Muscle Atrophy, Bariatric Surgery
What is being tested?
Zoledronic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
1 siteDenmark
Study dates
20 Feb 2021to 12 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Hospital South West Jutland

    Esbjerg, 6700

Other trials in Denmark

About this study

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

Read the detailed description

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.

Being tested
Zoledronic Acid, Placebo
Medical subject headings
Bone Diseases, Metabolic, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zoledronic AcidDrug

    • 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

  • PlaceboDrug

    as above

Study groups in NCT04742010
Study groupRoleWhat they receive
Zoledronic AcidExperimentalActive treatment
Receives: Drug: Zoledronic Acid
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantitative Computed Tomography (QCT)

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

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

Secondary outcomes (7)

  1. QCT

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

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

  2. Biochemical calcium-metabolic markers

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

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

  3. DEXA

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

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

  4. HR-pQCT

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

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

  5. Cortical bone stiffness

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

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

  6. Muscle Strength

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

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

  7. Physical function

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2021
  2. Study start20 Feb 2021
  3. Primary completion1 Nov 2023
  4. Study completion12 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04742010
Sponsor's protocol ID
20/41068
Acronym
ZABAS
Status last verified
Jun 2022
First submitted
27 Jan 2021
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29.

    PubMed 24880830

  • Arterburn D, Gupta A. Comparing the Outcomes of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass for Severe Obesity. JAMA. 2018 Jan 16;319(3):235-237. doi: 10.1001/jama.2017.20449. No abstract available.

    PubMed 29340659

  • Yu EW. Bone metabolism after bariatric surgery. J Bone Miner Res. 2014 Jul;29(7):1507-18. doi: 10.1002/jbmr.2226.

    PubMed 24677277

  • Rousseau C, Jean S, Gamache P, Lebel S, Mac-Way F, Biertho L, Michou L, Gagnon C. Change in fracture risk and fracture pattern after bariatric surgery: nested case-control study. BMJ. 2016 Jul 27;354:i3794. doi: 10.1136/bmj.i3794.

    PubMed 27814663

  • Yu EW, Lee MP, Landon JE, Lindeman KG, Kim SC. Fracture Risk After Bariatric Surgery: Roux-en-Y Gastric Bypass Versus Adjustable Gastric Banding. J Bone Miner Res. 2017 Jun;32(6):1229-1236. doi: 10.1002/jbmr.3101. Epub 2017 Mar 20.

    PubMed 28251687

  • Lalmohamed A, de Vries F, Bazelier MT, Cooper A, van Staa TP, Cooper C, Harvey NC. Risk of fracture after bariatric surgery in the United Kingdom: population based, retrospective cohort study. BMJ. 2012 Aug 3;345:e5085. doi: 10.1136/bmj.e5085.

    PubMed 22867649

  • Lu CW, Chang YK, Chang HH, Kuo CS, Huang CT, Hsu CC, Huang KC. Fracture Risk After Bariatric Surgery: A 12-Year Nationwide Cohort Study. Medicine (Baltimore). 2015 Dec;94(48):e2087. doi: 10.1097/MD.0000000000002087.

    PubMed 26632892

  • Nakamura KM, Haglind EG, Clowes JA, Achenbach SJ, Atkinson EJ, Melton LJ 3rd, Kennel KA. Fracture risk following bariatric surgery: a population-based study. Osteoporos Int. 2014 Jan;25(1):151-8. doi: 10.1007/s00198-013-2463-x. Epub 2013 Aug 3.

    PubMed 23912559

  • Axelsson KF, Werling M, Eliasson B, Szabo E, Naslund I, Wedel H, Lundh D, Lorentzon M. Fracture Risk After Gastric Bypass Surgery: A Retrospective Cohort Study. J Bone Miner Res. 2018 Dec;33(12):2122-2131. doi: 10.1002/jbmr.3553. Epub 2018 Aug 13.

    PubMed 30011091

  • Frederiksen KD, Hanson S, Hansen S, Brixen K, Gram J, Jorgensen NR, Stoving RK. Bone Structural Changes and Estimated Strength After Gastric Bypass Surgery Evaluated by HR-pQCT. Calcif Tissue Int. 2016 Mar;98(3):253-62. doi: 10.1007/s00223-015-0091-5. Epub 2015 Dec 12.

    PubMed 26661530

  • Andersen S, Frederiksen KD, Hansen S, Brixen K, Gram J, Stoving RK. Bone structure and estimated bone strength in obese patients evaluated by high-resolution peripheral quantitative computed tomography. Calcif Tissue Int. 2014 Jul;95(1):19-28. doi: 10.1007/s00223-014-9857-4. Epub 2014 Apr 17.

    PubMed 24736885

  • Shanbhogue VV, Stoving RK, Frederiksen KH, Hanson S, Brixen K, Gram J, Jorgensen NR, Hansen S. Bone structural changes after gastric bypass surgery evaluated by HR-pQCT: a two-year longitudinal study. Eur J Endocrinol. 2017 Jun;176(6):685-693. doi: 10.1530/EJE-17-0014. Epub 2017 Mar 13.

    PubMed 28289103

  • Lindeman KG, Greenblatt LB, Rourke C, Bouxsein ML, Finkelstein JS, Yu EW. Longitudinal 5-Year Evaluation of Bone Density and Microarchitecture After Roux-en-Y Gastric Bypass Surgery. J Clin Endocrinol Metab. 2018 Nov 1;103(11):4104-4112. doi: 10.1210/jc.2018-01496.

    PubMed 30219833

  • Muschitz C, Kocijan R, Marterer C, Nia AR, Muschitz GK, Resch H, Pietschmann P. Sclerostin levels and changes in bone metabolism after bariatric surgery. J Clin Endocrinol Metab. 2015 Mar;100(3):891-901. doi: 10.1210/jc.2014-3367. Epub 2014 Dec 9.

    PubMed 25490275

  • Gagnon C, Schafer AL. Bone Health After Bariatric Surgery. JBMR Plus. 2018 May 1;2(3):121-133. doi: 10.1002/jbm4.10048. eCollection 2018 May.

    PubMed 30283897

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zoledronic Acid in people with Bone Loss and Muscle Atrophy, run by Stinus Gadegaard Hansen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantitative Computed Tomography (QCT) (time frame: Change from baseline to 12 and 24 months after bariatric surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04742010, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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