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| Name | Class |
|---|---|
| Research Unit of Health Sciences, Hospital of South West Jutland | UNKNOWN |
| University of Southern Denmark | OTHER |
| OPEN - Odense Patient data Explorative Network, The University of Southern Denmark, Odense, Denmark |
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In a randomised placebo-controlled trial assess effects of zoledronic acid for prevention of bone and muscle loss after bariatric surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronic Acid | Experimental | Active treatment |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| QCT | Volumetric BMD at the proximal femur (Mindways QCT Pro software, Texas, USA). | Change from baseline to 12 and 24 months after bariatric surgery |
| Biochemical calcium-metabolic markers | Calcium, parathyroid hormone, vitamin D and markers of bone remodeling (CTX, P1NP). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital South West Jutland | Esbjerg | 6700 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24880830 | Background | 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. |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Department of Radiology and Nuclear Medicine, Hospital of Southwest Jutland, 6700 Esbjerg, Denmark | UNKNOWN |
| Odense University Hospital | OTHER |
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|
| Placebo | Drug | as above |
|
| Change from baseline to 12 and 24 months after bariatric surgery |
| DEXA | Bone mineral density at the lumbar spine and total hip (Hologic Discovery, Waltham, MA, US). | Change from baseline to 12 and 24 months after bariatric surgery |
| HR-pQCT | Radius and tibia bone microarchitecture (Scanco Medical AG, Brutisellen, Switzerland). | Change from baseline to 12 and 24 months after bariatric surgery |
| 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). | Change from baseline to 12 and 24 months after bariatric surgery |
| Muscle Strength | Upper and lower limb muscle strength assessed using dynamometers (foot, knee, shoulder, hand) | Change from baseline to 12 and 24 months after bariatric surgery |
| Physical function | Short physical performance battery (SPPB), Stair Climb, 2 minute walking test | Change from baseline to 12 and 24 months after bariatric surgery |
| 29340659 | Background | 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. |
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| 27814663 | Background | 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. |
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| 28289103 | Background | 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. |
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| 41177144 | Derived | 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. |
| 36209245 | Derived | 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. |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |