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Clinical Diabetes & Therapeutics
Effects of Lobeglitazone, a Novel Thiazolidinedione, on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus over 52 Weeks
Soo Lim, Kyoung Min Kim, Sin Gon Kim, Doo Man Kim, Jeong-Taek Woo, Choon Hee Chung, Kyung Soo Ko, Jeong Hyun Park, Yongsoo Park, Sang Jin Kim, Hak Chul Jang, Dong Seop Choi
Diabetes Metab J. 2017;41(5):377-385.   Published online October 24, 2017
DOI: https://doi.org/10.4093/dmj.2017.41.5.377
  • 4,206 View
  • 41 Download
  • 19 Web of Science
  • 20 Crossref
AbstractAbstract PDFPubReader   
Background

The aim of this multicenter, randomized, double-blind study was to examine the effect of lobeglitazone, a novel thiazolidinedione, on the changes in bone mineral density (BMD) in patients with type 2 diabetes mellitus.

Methods

A 24-week, double-blinded phase was followed by a 28-week, open-label phase, in which the placebo group also started to receive lobeglitazone. A total of 170 patients aged 34 to 76 years were randomly assigned in a 2:1 ratio to receive lobeglitazone 0.5 mg or a matching placebo orally, once daily. BMD was assessed using dual-energy X-ray absorptiometry at week 24 and at the end of the study (week 52).

Results

During the double-blinded phase, the femur neck BMD showed decreasing patterns in both groups, without statistical significance (−0.85%±0.36% and −0.78%±0.46% in the lobeglitazone and placebo groups, respectively). The treatment difference between the groups was 0.07%, which was also not statistically significant. Further, minimal, nonsignificant decreases were observed in both groups in the total hip BMD compared to values at baseline, and these differences also did not significantly differ between the groups. During the open-label phase, the BMD was further decreased, but not significantly, by −0.32% at the femur neck and by −0.60% at the total hip in the lobeglitazone group, and these changes did not significantly differ compared with the original placebo group switched to lobeglitazone.

Conclusion

Our results indicate that treatment with lobeglitazone 0.5 mg over 52 weeks showed no detrimental effect on the BMD compared to the placebo.

Citations

Citations to this article as recorded by  
  • Efficacy and safety of novel thiazolidinedione lobeglitazone for managing type-2 diabetes a meta-analysis
    Deep Dutta, Saptarshi Bhattacharya, Manoj Kumar, Priyankar K. Datta, Ritin Mohindra, Meha Sharma
    Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(1): 102697.     CrossRef
  • Efficacy and safety of lobeglitazone, a new Thiazolidinedione, as compared to the standard of care in type 2 diabetes mellitus: A systematic review and meta-analysis
    Shashank R. Joshi, Saibal Das, Suja Xaviar, Shambo Samrat Samajdar, Indranil Saha, Sougata Sarkar, Shatavisa Mukherjee, Santanu Kumar Tripathi, Jyotirmoy Pal, Nandini Chatterjee
    Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(1): 102703.     CrossRef
  • The benefits of adipocyte metabolism in bone health and regeneration
    Lisa-Marie Burkhardt, Christian H. Bucher, Julia Löffler, Charlotte Rinne, Georg N. Duda, Sven Geissler, Tim J. Schulz, Katharina Schmidt-Bleek
    Frontiers in Cell and Developmental Biology.2023;[Epub]     CrossRef
  • Will lobeglitazone rival pioglitazone? A systematic review and critical appraisal
    Kalyan Kumar Gangopadhyay, Awadhesh Kumar Singh
    Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(4): 102747.     CrossRef
  • Comparison of therapeutic efficacy and safety of sitagliptin, dapagliflozin, or lobeglitazone adjunct therapy in patients with type 2 diabetes mellitus inadequately controlled on sulfonylurea and metformin: Third agent study
    Jun Hwa Hong, Jun Sung Moon, Kayeon Seong, Soo Lim
    Diabetes Research and Clinical Practice.2023; 203: 110872.     CrossRef
  • Bone Mineral Density Evaluation Among Type 2 Diabetic Patients in Rural Haryana, India: An Analytical Cross-Sectional Study
    Nitish Khandelwal, Surbhi Rajauria, Siddhesh Pandurang Kanjalkar, Omkar Shivaji Chavanke, Sanjay Rai
    Cureus.2023;[Epub]     CrossRef
  • Lobeglitazone and Its Therapeutic Benefits: A Review
    Balamurugan M, Sarumathy S, Robinson R
    Cureus.2023;[Epub]     CrossRef
  • A double‐blind, Randomized controlled trial on glucose‐lowering EFfects and safety of adding 0.25 or 0.5 mg lobeglitazone in type 2 diabetes patients with INadequate control on metformin and dipeptidyl peptidase‐4 inhibitor therapy: REFIND study
    Soree Ryang, Sang Soo Kim, Ji Cheol Bae, Ji Min Han, Su Kyoung Kwon, Young Il Kim, Il Seong Nam‐Goong, Eun Sook Kim, Mi‐kyung Kim, Chang Won Lee, Soyeon Yoo, Gwanpyo Koh, Min Jeong Kwon, Jeong Hyun Park, In Joo Kim
    Diabetes, Obesity and Metabolism.2022; 24(9): 1800.     CrossRef
  • A Real-World Study of Long-Term Safety and Efficacy of Lobeglitazone in Korean Patients with Type 2 Diabetes Mellitus
    Bo-Yeon Kim, Hyuk-Sang Kwon, Suk Kyeong Kim, Jung-Hyun Noh, Cheol-Young Park, Hyeong-Kyu Park, Kee-Ho Song, Jong Chul Won, Jae Myung Yu, Mi Young Lee, Jae Hyuk Lee, Soo Lim, Sung Wan Chun, In-Kyung Jeong, Choon Hee Chung, Seung Jin Han, Hee-Seok Kim, Ju-Y
    Diabetes & Metabolism Journal.2022; 46(6): 855.     CrossRef
  • Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus
    Kyung-Soo Kim, Sangmo Hong, Hong-Yup Ahn, Cheol-Young Park
    Diabetes Therapy.2021; 12(1): 171.     CrossRef
  • Lobeglitazone: A Novel Thiazolidinedione for the Management of Type 2 Diabetes Mellitus
    Jaehyun Bae, Taegyun Park, Hyeyoung Kim, Minyoung Lee, Bong-Soo Cha
    Diabetes & Metabolism Journal.2021; 45(3): 326.     CrossRef
  • Effect of lobeglitazone on motor function in rat model of Parkinson’s disease with diabetes co-morbidity
    Kambiz Hassanzadeh, Arman Rahimmi, Mohammad Raman Moloudi, Rita Maccarone, Massimo Corbo, Esmael Izadpanah, Marco Feligioni
    Brain Research Bulletin.2021; 173: 184.     CrossRef
  • Recent Perspective on Thiazolidinedione
    Won Jun Kim
    The Journal of Korean Diabetes.2021; 22(2): 97.     CrossRef
  • Use of in vitro bone models to screen for altered bone metabolism, osteopathies, and fracture healing: challenges of complex models
    Sabrina Ehnert, Helen Rinderknecht, Romina H. Aspera-Werz, Victor Häussling, Andreas K. Nussler
    Archives of Toxicology.2020; 94(12): 3937.     CrossRef
  • Update on: effects of anti-diabetic drugs on bone metabolism
    Guillaume Mabilleau, Béatrice Bouvard
    Expert Review of Endocrinology & Metabolism.2020; 15(6): 415.     CrossRef
  • The use of metformin, insulin, sulphonylureas, and thiazolidinediones and the risk of fracture: Systematic review and meta‐analysis of observational studies
    Khemayanto Hidayat, Xuan Du, Meng‐Jiao Wu, Bi‐Min Shi
    Obesity Reviews.2019; 20(10): 1494.     CrossRef
  • Diabetes pharmacotherapy and effects on the musculoskeletal system
    Evangelia Kalaitzoglou, John L. Fowlkes, Iuliana Popescu, Kathryn M. Thrailkill
    Diabetes/Metabolism Research and Reviews.2019;[Epub]     CrossRef
  • Morin Exerts Anti‐Arthritic Effects by Attenuating Synovial Angiogenesis via Activation of Peroxisome Proliferator Activated Receptor‐γ
    Mengfan Yue, Ni Zeng, Yufeng Xia, Zhifeng Wei, Yue Dai
    Molecular Nutrition & Food Research.2018;[Epub]     CrossRef
  • The effects of diabetes therapy on bone: A clinical perspective
    Karim G. Kheniser, Carmen M. Polanco Santos, Sangeeta R. Kashyap
    Journal of Diabetes and its Complications.2018; 32(7): 713.     CrossRef
  • Changes in the Bone Mineral Density of Femur Neck and Total Hip Over a 52-Week Treatment with Lobeglitazone
    Da Young Lee, Ji A Seo
    Diabetes & Metabolism Journal.2017; 41(5): 374.     CrossRef
Bone Mineral Density in Prediabetic Men
Ju Hee Lee, Yun Hyeong Lee, Kyoung Hye Jung, Min Kyeong Kim, Hye Won Jang, Tae Kyun Kim, Hyun Jin Kim, Young Suk Jo, Minho Shong, Tae Yong Lee, Bon Jeong Ku
Korean Diabetes J. 2010;34(5):294-302.   Published online October 31, 2010
DOI: https://doi.org/10.4093/kdj.2010.34.5.294
  • 4,403 View
  • 30 Download
  • 12 Crossref
AbstractAbstract PDFPubReader   
Background

There are many studies regarding the effects of insulin on bone metabolism and changes in bone mineral density (BMD) in the setting of diabetes. The effect of prediabetes on BMD is not known.

Methods

A total of 802 men participated in the Korea Rural Genomic Cohort Study (in Geumsan County). According to the results of an oral glucose tolerance test, subjects were classified into normal, prediabetic, and diabetic categories. One hundred twenty-four subjects diagnosed with type 2 diabetes were excluded, leaving 678 subjects for the study inclusion. BMD was estimated with a quantitative ultrasonometer.

Results

The average BMD T scores of normal and prediabetic subjects were -1.34 ± 1.42 and -1.33 ± 1.30, respectively; there was no significant difference in the BMD T scores between these groups. The BMD T score was inversely associated with age and positively correlated with body weight, body mass index, total cholesterol, low density lipoprotein cholesterol, and HbA1c. On multiple linear regression analysis, low density lipoprotein cholesterol was the only statistically significant variable for prediabetes (β = 0.007, P = 0.005). On the stepwise regression analysis, age (β = -0.026, P < 0.001), the body mass index (β = 0.079, P < 0.001), and low density lipoprotein cholesterol (β = 0.004, P = 0.016) were significant variables for prediabetes.

Conclusions

There was no significant difference in the BMD T score between the normal and prediabetic subjects. Further studies are needed regarding the association of fracture risk and changes in BMD with the development of overt diabetes.

Citations

Citations to this article as recorded by  
  • More Rapid Bone Mineral Density Loss in Older Men With Diabetes: The Osteoporotic Fractures in Men (MrOS) Study
    Flavia Tramontana, Nicola Napoli, Stephanie Litwack-Harrison, Douglas C Bauer, Eric S Orwoll, Jane A Cauley, Elsa S Strotmeyer, Ann V Schwartz
    The Journal of Clinical Endocrinology & Metabolism.2024;[Epub]     CrossRef
  • Prediabetes and skeletal health
    Catherine Lindsay, Albert Shieh
    Current Opinion in Endocrinology, Diabetes & Obesity.2023; 30(4): 200.     CrossRef
  • Serum levels of sclerostin in prediabetes and its correlation with bone mineral density
    Ajay Chauhan, Manoj Kumar Bhakhar, Parul Goyal
    Journal of Family Medicine and Primary Care.2023; 12(11): 2702.     CrossRef
  • The risk of hip fractures in individuals over 50 years old with prediabetes and type 2 diabetes – A longitudinal nationwide population-based study
    Ho Youn Park, Kyoungdo Han, Youngwoo Kim, Yoon Hwan Kim, Yoo Joon Sur
    Bone.2021; 142: 115691.     CrossRef
  • Bone health in diabetes and prediabetes
    Silvia Costantini, Caterina Conte
    World Journal of Diabetes.2019; 10(8): 421.     CrossRef
  • Bone mineral density in obese children with prediabetes
    Ala ÜSTYOL, Mehmet Emre ATABEK
    Ege Tıp Dergisi.2018; 57(2): 94.     CrossRef
  • The Prevalence of Osteopenia and Osteoporosis Among Malaysian Type 2 Diabetic Patients Using Quantitative Ultrasound Densitometer
    Shaymaa Abdalwahed Abdulameer, Mohanad Naji Sahib, Syed Azhar Syed Sulaiman
    The Open Rheumatology Journal.2018; 12(1): 50.     CrossRef
  • An association between bone mineral density and anabolic hormones in middle-aged and elderly men with prediabetes
    Michał Rabijewski, Lucyna Papierska, Paweł Piątkiewicz
    The Aging Male.2017; : 1.     CrossRef
  • Amplification of transcutaneous and percutaneous bone-conduction devices with a test-band in an induced model of conductive hearing loss
    Marn Joon Park, Jae Ryung Lee, Chan Joo Yang, Myung Hoon Yoo, In Suk Jin, Chi Ho Choi, Hong Ju Park
    International Journal of Audiology.2016; 55(11): 653.     CrossRef
  • Osteoporosis in Men with Diabetes Mellitus
    Claire Issa, Mira S. Zantout, Sami T. Azar
    Journal of Osteoporosis.2011; 2011: 1.     CrossRef
  • Response: Bone Mineral Density in Prediabetic Men (Korean Diabetes J 2010;34:294-302)
    Ju Hee Lee, Hyun Jin Kim, Bon Jeong Ku
    Korean Diabetes Journal.2010; 34(6): 386.     CrossRef
  • Letter: Bone Mineral Density in Prediabetic Men (Korean Diabetes J 2010;34:294-302)
    Chul-Hee Kim
    Korean Diabetes Journal.2010; 34(6): 384.     CrossRef
Leptin is Negatively Associated with Femoral Bone Mineral Density in Postmenopausal Women with Type 2 Diabetes Mellitus.
Jae Han Jeon, Yeun Kyung Choi, Hyun Ae Seo, Jung Eun Lee, Ji Yun Jeong, Seong Su Moon, Ju Young Lee, Jung Guk Kim, Bo Wan Kim, In Kyu Lee
Korean Diabetes J. 2009;33(5):421-431.   Published online October 1, 2009
DOI: https://doi.org/10.4093/kdj.2009.33.5.421
  • 2,127 View
  • 18 Download
  • 1 Crossref
AbstractAbstract PDF
BACKGROUND
Serum leptin level and bone mineral density (BMD) are widely assumed to be positively associated with body fat mass. Numerous attempts have been made to document the relationship between leptin and BMD, but the results are inconsistent, especially in diabetic patients. METHODS: A total of 60 Korean postmenopausal women with type 2 diabetes mellitus were included in the present study. The BMDs of lumbar spines (L1 to L4) and proximal femurs (trochanter, neck, and total) were measured by dual-energy X-ray absorptiometry (DXA), and biochemical markers including leptin, HbA1c, C-peptide and urine albumin-creatinine ratio (ACR) were measured for each patient. RESULTS: Negative associations between leptin and BMD of femoral neck, trochanter, and total femur in postmenopausal women with type 2 diabetes mellitus were documented in a model adjusted for age, body fat mass, and fasting insulin level (r = -0.308, P = 0.020 and r = - 0.303, P = 0.025 and r = - 0.290, P = 0.032 respectively). Multiple linear regression analysis was performed revealing negative associations between leptin and BMD of the femoral neck (beta = -0.369), trochanter (beta = -0.324), and total femur (beta = -0.317). CONCLUSION: The results of the present study suggest a negative relationship between leptin and femoral BMD. In addition, leptin may have a negative effect on BMD in postmenopausal women with type 2 diabetes mellitus.

Citations

Citations to this article as recorded by  
  • Evaluation of bone mineral density in type 2 diabetes mellitus patients before and after treatment
    MK Dutta, R Pakhetra, MK Garg
    Medical Journal Armed Forces India.2012; 68(1): 48.     CrossRef

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