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

Summary

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

Timeline

Start

2021-02-20

Primary completion

2023-11-01

Completion

2024-08-12

Publications

• 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.
• 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.
• Background Yu EW. Bone metabolism after bariatric surgery. J Bone Miner Res. 2014 Jul;29(7):1507-18. doi: 10.1002/jbmr.2226.
• 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• 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.
• Background 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.
• Background 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.
• Background 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.
• Background Schafer AL, Weaver CM, Black DM, Wheeler AL, Chang H, Szefc GV, Stewart L, Rogers SJ, Carter JT, Posselt AM, Shoback DM, Sellmeyer DE. Intestinal Calcium Absorption Decreases Dramatically After Gastric Bypass Surgery Despite Optimization of Vitamin D Status. J Bone Miner Res. 2015 Aug;30(8):1377-85. doi: 10.1002/jbmr.2467. Epub 2015 May 21.
• Background Yu EW, Wewalka M, Ding SA, Simonson DC, Foster K, Holst JJ, Vernon A, Goldfine AB, Halperin F. Effects of Gastric Bypass and Gastric Banding on Bone Remodeling in Obese Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2016 Feb;101(2):714-22. doi: 10.1210/jc.2015-3437. Epub 2015 Nov 24.
• Background Muschitz C, Kocijan R, Haschka J, Zendeli A, Pirker T, Geiger C, Muller A, Tschinder B, Kocijan A, Marterer C, Nia A, Muschitz GK, Resch H, Pietschmann P. The Impact of Vitamin D, Calcium, Protein Supplementation, and Physical Exercise on Bone Metabolism After Bariatric Surgery: The BABS Study. J Bone Miner Res. 2016 Mar;31(3):672-82. doi: 10.1002/jbmr.2707. Epub 2015 Sep 30.
• Background Mundbjerg LH, Stolberg CR, Bladbjerg EM, Funch-Jensen P, Juhl CB, Gram B. Effects of 6 months supervised physical training on muscle strength and aerobic capacity in patients undergoing Roux-en-Y gastric bypass surgery: a randomized controlled trial. Clin Obes. 2018 Aug;8(4):227-235. doi: 10.1111/cob.12256. Epub 2018 Jun 12.
• Background Frost HM. Bone's mechanostat: a 2003 update. Anat Rec A Discov Mol Cell Evol Biol. 2003 Dec;275(2):1081-101. doi: 10.1002/ar.a.10119.
• Background Tagliaferri C, Wittrant Y, Davicco MJ, Walrand S, Coxam V. Muscle and bone, two interconnected tissues. Ageing Res Rev. 2015 May;21:55-70. doi: 10.1016/j.arr.2015.03.002. Epub 2015 Mar 21.
• Background Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR; HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007 May 3;356(18):1809-22. doi: 10.1056/NEJMoa067312.
• Background Boonen S, Reginster JY, Kaufman JM, Lippuner K, Zanchetta J, Langdahl B, Rizzoli R, Lipschitz S, Dimai HP, Witvrouw R, Eriksen E, Brixen K, Russo L, Claessens F, Papanastasiou P, Antunez O, Su G, Bucci-Rechtweg C, Hruska J, Incera E, Vanderschueren D, Orwoll E. Fracture risk and zoledronic acid therapy in men with osteoporosis. N Engl J Med. 2012 Nov 1;367(18):1714-23. doi: 10.1056/NEJMoa1204061.
• Background Deas CM, Murphy P, Iranikhah M, Freeman MK. Retained Skeletal Effects of Zoledronic Acid Following Discontinuation of Treatment: A Review of the Literature. Consult Pharm. 2017 Mar 1;32(3):144-155. doi: 10.4140/TCP.n.2017.144.
• Background Watanabe R, Fujita N, Takeda S, Sato Y, Kobayashi T, Morita M, Oike T, Miyamoto K, Matsumoto Y, Matsumoto M, Nakamura M, Miyamoto T. Ibandronate concomitantly blocks immobilization-induced bone and muscle atrophy. Biochem Biophys Res Commun. 2016 Nov 25;480(4):662-668. doi: 10.1016/j.bbrc.2016.10.112. Epub 2016 Oct 27.
• Background Borsheim E, Herndon DN, Hawkins HK, Suman OE, Cotter M, Klein GL. Pamidronate attenuates muscle loss after pediatric burn injury. J Bone Miner Res. 2014 Jun;29(6):1369-72. doi: 10.1002/jbmr.2162.
• 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.
• 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.

Drugs

Indications