Effects of Pioglitazone on Bone in Postmenopausal Women With Impaired Fasting Glucose or Impaired Glucose Tolerance: A Randomized, Double-Blind, Placebo-Controlled Study (original) (raw)

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1Michigan Bone and Mineral Clinic (H.G.B.), Detroit, Michigan 48236

*Address all correspondence and requests for reprints to: Henry G. Bone, MD, Director, Michigan Bone and Mineral Clinic, 22201 Moross Road, Suite 260, Detroit, MI 48236-2175.

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2Regional Bone Center (R.L.), Helen Hayes Hospital, West Haverstraw, New York 10993

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3Oregon Osteoporosis Center (M.R.M.), Portland, Oregon 97213

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4Takeda Global Research and Development Center, Inc (A.T.P., M.G.R.), Deerfield, Illinois 60015

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4Takeda Global Research and Development Center, Inc (A.T.P., M.G.R.), Deerfield, Illinois 60015

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5Takeda Pharmaceuticals North America, Inc (R.G.S.), Deerfield, Illinois 60015

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Received:

04 December 2012

Accepted:

11 September 2013

Published:

01 December 2013

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Henry G. Bone, Robert Lindsay, Michael R. McClung, Alfonso T. Perez, Marsha G. Raanan, Robert G. Spanheimer, Effects of Pioglitazone on Bone in Postmenopausal Women With Impaired Fasting Glucose or Impaired Glucose Tolerance: A Randomized, Double-Blind, Placebo-Controlled Study, The Journal of Clinical Endocrinology & Metabolism, Volume 98, Issue 12, 1 December 2013, Pages 4691–4701, https://doi.org/10.1210/jc.2012-4096
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Context:

Meta-analyses of clinical studies have suggested an increased incidence of peripheral fractures in postmenopausal women with type 2 diabetes mellitus taking pioglitazone. The mechanism behind this apparent increase is unknown.

Objective:

The objective of the study was to examine the effects of pioglitazone on bone mineral density (BMD) and turnover.

Design and Setting:

Twenty-five sites (in the United States) enrolled participants in this randomized, double-blind, placebo-controlled study.

Participants:

Postmenopausal women (n = 156) with impaired fasting glucose or impaired glucose tolerance participated in the study.

Interventions:

The intervention consisted of pioglitazone 30 mg/d (n = 78) or placebo (n = 78), increased to 45 mg/d after 1 month, for 12 months of treatment total, followed by 6 months of washout/follow-up.

Main Outcome Measures:

Percentage changes from baseline to month 12 and from month 12 to month18 in BMD in total proximal femur (primary end point), total body, femoral neck, lumbar spine, and radius were measured.

Results:

Least squares mean changes from baseline to month 12 in total proximal femur BMD were −0.69% for pioglitazone and −0.14% for placebo (P = .170). No statistically significant between-group differences were observed for any BMD or bone remodeling marker end point. We observed improved glycemic control and insulin sensitivity with pioglitazone treatment. In addition, pioglitazone appeared to increase body fat, which may affect bone density measurements, especially in the lumbar spine. One pioglitazone-treated and three placebo-treated women experienced confirmed fractures. Over 18 months, one pioglitazone-treated (1.3%) and eight placebo-treated women (10.3%) developed overt type 2 diabetes mellitus. The pattern and incidence of adverse events with pioglitazone were consistent with clinical experience with thiazolidinediones.

Conclusions:

Maximal-dose pioglitazone had no effects on BMD or bone turnover, while improving glycemic control as expected, in postmenopausal women with impaired fasting glucose or impaired glucose tolerance.

Copyright © 2013 by The Endocrine Society

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