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

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Abstract

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.

Original languageEnglish
Pages (from-to)377-385
Number of pages9
JournalDiabetes and Metabolism Journal
Volume41
Issue number5
DOIs
Publication statusPublished - 2017 Oct 1

Fingerprint

Bone Density
Type 2 Diabetes Mellitus
Placebos
Femur Neck
Pelvic Bones
Photon Absorptiometry
2,4-thiazolidinedione
lobeglitazone
Double-Blind Method
Hip
Therapeutics

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism

Cite this

Lim, Soo ; Kim, Kyoung Min ; Kim, Sin Gon ; Kim, Doo Man ; Woo, Jeong Taek ; Chung, Choon Hee ; Ko, Kyung Soo ; Park, Jeong Hyun ; Park, Yongsoo ; Kim, Sang Jin ; Jang, Hak Chul ; Choi, Dong Seop. / Effects of lobeglitazone, a novel thiazolidinedione, on bone mineral density in patients with type 2 diabetes mellitus over 52 weeks. In: Diabetes and Metabolism Journal. 2017 ; Vol. 41, No. 5. pp. 377-385.
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title = "Effects of lobeglitazone, a novel thiazolidinedione, on bone mineral density in patients with type 2 diabetes mellitus over 52 weeks",
abstract = "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.",
author = "Soo Lim and Kim, {Kyoung Min} and Kim, {Sin Gon} and Kim, {Doo Man} and Woo, {Jeong Taek} and Chung, {Choon Hee} and Ko, {Kyung Soo} and Park, {Jeong Hyun} and Yongsoo Park and Kim, {Sang Jin} and Jang, {Hak Chul} and Choi, {Dong Seop}",
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Effects of lobeglitazone, a novel thiazolidinedione, on bone mineral density in patients with type 2 diabetes mellitus over 52 weeks. / Lim, Soo; Kim, Kyoung Min; Kim, Sin Gon; Kim, Doo Man; Woo, Jeong Taek; Chung, Choon Hee; Ko, Kyung Soo; Park, Jeong Hyun; Park, Yongsoo; Kim, Sang Jin; Jang, Hak Chul; Choi, Dong Seop.

In: Diabetes and Metabolism Journal, Vol. 41, No. 5, 01.10.2017, p. 377-385.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Effects of lobeglitazone, a novel thiazolidinedione, on bone mineral density in patients with type 2 diabetes mellitus over 52 weeks

AU - Lim, Soo

AU - Kim, Kyoung Min

AU - Kim, Sin Gon

AU - Kim, Doo Man

AU - Woo, Jeong Taek

AU - Chung, Choon Hee

AU - Ko, Kyung Soo

AU - Park, Jeong Hyun

AU - Park, Yongsoo

AU - Kim, Sang Jin

AU - Jang, Hak Chul

AU - Choi, Dong Seop

PY - 2017/10/1

Y1 - 2017/10/1

N2 - 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.

AB - 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.

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