title: Rosiglitazone decreases bone mineral density and increases bone turnover in postmenopausal women with type 2 diabetes mellitus.
abstract: BACKGROUND
  Postmenopausal status and type 2 diabetes mellitus (T2DM) are independent risk factors for fractures. An increased fracture risk has been observed with rosiglitazone (RSG), a thiazolidinedione, in patients with T2DM.
  
  
  METHODS
  This was a randomized, double-blind study in postmenopausal women with T2DM. A 52-week double-blind phase (RSG or metformin [MET]) was followed by a 24-week open-label phase, during which time all patients received MET.
  
  
  METHODS
  The primary endpoint was to assess the mean percentage change in bone mineral density (BMD) at the femoral neck (FN) by dual-energy x-ray absorptiometry from baseline to week 52 in the RSG treatment group. Key secondary objectives included assessment of changes in BMD at the total hip, trochanter, and lumbar spine and to evaluate RSG effects on bone turnover markers.
  
  
  RESULTS
  From baseline to week 52, RSG was associated with a reduction in FN BMD by dual-energy x-ray absorptiometry (-1.47%). During the open-label phase (weeks 52-76), no further loss in FN BMD was observed. A decrease in BMD occurred at the total hip during RSG or MET treatment at 52 weeks (-1.62 and -0.72%, respectively). Total hip BMD loss by RSG was attenuated after switching to MET and was similar between treatment groups at the end of the open-label phase. From baseline to week 52, bone turnover markers significantly increased with RSG compared with MET, but decreased significantly during the open-label phase.
  
  
  CONCLUSIONS
  RSG for 52 weeks in postmenopausal women with T2DM was associated with small reductions in FN, total hip, and lumbar spine BMD and increased bone turnover markers. These effects are attenuated after cessation of RSG treatment.
authors: Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.
authors: John P
authors: JP
authors: Bilezikian
authors: Robert G
authors: RG
authors: Josse
authors: Richard
authors: R
authors: Eastell
authors: E Michael
authors: EM
authors: Lewiecki
authors: Colin G
authors: CG
authors: Miller
authors: Margaret
authors: M
authors: Wooddell
authors: Allison R
authors: AR
authors: Northcutt
authors: Barbara G
authors: BG
authors: Kravitz
authors: Gitanjali
authors: G
authors: Paul
authors: Alexander R
authors: AR
authors: Cobitz
authors: Antonio J
authors: AJ
authors: Nino
authors: Lorraine A
authors: LA
authors: Fitzpatrick
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000187:drug effects*; D016723:Bone Remodeling / Q000187:drug effects*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D015536:Down-Regulation / Q000187:drug effects; D057915:Drug Substitution; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D008687:Metformin / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects*; D000077154:Rosiglitazone; D045162:Thiazolidinediones / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone; D008687:Metformin