Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access
Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc
Journal website http://www.jocmr.org

Original Article

Volume 7, Number 10, October 2015, pages 762-769


The Effects of Bazedoxifene on Bone, Glucose, and Lipid Metabolism in Postmenopausal Women With Type 2 Diabetes: An Exploratory Pilot Study

Figure

Figure 1.
Figure 1. Median percent changes in bone metabolism after 12 weeks of bazedoxifene treatment. Median values (first quartile, third quartile) are -18.6% (-30.9%, 12.9%) for u-NTX, -10.2% (-44.1%, 20.7%) for u-CTX, -20.6% (-27.8%, -5.8%) for TRACP, -10.1% (-17.7%, 8.6%) for OC, and -16.3% (-23.4%, -2.2%) for ucOC. u-NTX: urinary type I collagen cross-linked N-telopeptide; u-CTX: urinary type I collagen cross-linked C-telopeptide; TRACP: tartrate-resistant acid phosphatase 5b; OC: osteocalcin; ucOC: undercarboxylated osteocalcin.

Tables

Table 1. Patients’ Baseline Characteristics
 
Baseline (n = 20)
Data are reported as means ± standard deviation or medians (min - max). BMI: body mass index; YAM: young adult mean; FRAX® tool: Fracture Risk Assessment Tool; ARBs: angiotensin II receptor blocker.
Age (years)67.9 ± 5.5
Menopause age (years)50.2 ± 5.1
Diabetes duration (years)4.5 (1 - 24)
Height (cm)153.5 ± 4.4
BMI (kg/m2)22.5 ± 2.8
HbA1c (%)6.3 (5.4 - 7.4)
Serum creatinine (mg/dL)0.61 (0.39 - 0.82)
Microangiopathy
  Neuropathy (%)29 (5/17)
  Retinopathy (%)0 (0/17)
  Nephropathy (%)
    Stage 182 (14/17)
    Stage 218 (3/17)
Macroangiopathy
  Coronary artery disease (%)5.9 (1/17)
  Cerebrovascular disease (%)24 (4/17)
  Peripheral artery disease (%)0 (0/17)
Smoking (%)
  Former smoker20 (5/20)
  Current smoker0 (0/20)
Alcohol (%)0 (0/20)
Lumbar
  Bone mineral density (g/cm2)0.9 ± 0.2
  T-score-1.3 ± 1.6
  YAM (%)86.4 ± 17.0
Femoral neck
  Bone mineral density (g/cm2)0.6 ± 0.1
  T-score-1.6 ± 0.8
  YAM (%)78.2 ± 10.9
FRAX® tool
  Major osteoporotic (years)8.3 (5.2 - 24)
  Hip fracture (years)1.3 (0.4 - 7.6)
History of the vertebral fracture0 (0/20)
History of the non-vertebral fracture0 (0/20)
Family history of the femoral neck fracture0 (0/20)
Medications
  Anti-diabetes
    Diet only (%)15 (3/20)
    Sulfonylureas (%)20 (4/20)
    Glinides (%)10 (2/20)
    Biguanides (%)25 (5/20)
    DPP-IV inhibitors (%)45 (9/20)
    GLP-1 analogues (%)10 (2/20)
    α-glucosidase inhibitors (%)5 (1/20)
    Insulin (%)5 (1/20)
  Anti-dyslipidemia
    Stains (%)35 (7/20)
    Ezetimibe (%)15 (3/20)
  Anti-hypertension
    ARBs (%)30 (6/20)

 

Table 2. Values of All Clinical Parameters From 0 to 12 Weeks
 
0 weeks4 weeks12 weeksP value vs. 4 weeksP value vs. 12 weeks
*Data are reported as medians (min - max). **Patients with insulin therapy (n = 1) were excluded from analysis of HOMA-IR and HOMA-β. UACR: urinary albumin-to-creatinine ratio; NS: no significance.
uNTX (nmol BCE/mmol CRE)36.9 (16.4 - 126)28.3 (15.2 - 66.9)29.7 (20.5 - 74.4)0.008NS
uCTX (μg/mmol CRE)232 (57 - 666)180 (57-390)181 (70-414)0.011NS
TRACP-5b (mU/dL)325 (155 - 606)257 (149 - 472)259 (141 - 388)< 0.001< 0.001
Osteocalcin (ng/mL)7.7 (4.6 - 13)7.8 (5.3 - 12)7.1 (5.3 - 10)NSNS
Undercarboxylated osteocalcin (ng/mL)3.6 (0.9 - 12)3.7 (1.6 - 10)3.3 (1.6 - 6.9)0.0020.04
Homocysteine (mmol/mL)6.1 (4.5 - 11.7)6.2 (4.6 - 13.2)6.4 (4.3 - 12.4)NSNS
Serum pentosidine (μg/mL)0.042 (0.022 - 0.065)0.043 (0.031 - 0.069)0.045 (0.038 - 0.076)NSNS
Fasting plasma glucose (mg/dL)112 (75 - 174)100 (88 - 158)105 (78 - 161)NSNS
HbA1c (%)6.3 (5.4 - 7.4)6.4 (5.5 - 7.3)6.2 (5.5 - 7.0)NSNS
IRI (μU/mL)5.31 (2.21 - 10.7)5.33 (2.24 - 11.6)5.54 (2.28 - 12.8)NSNS
sCPR (ng/mL)1.42 (0.33 - 2.73)1.4 (0.88 - 3.09)1.47 (0.14 - 2.86)NSNS
HOMA-IR**1.4 (0.5 - 3.2)1.3 (0.5 - 2.8)1.5 (0.9 - 3.4)0.02NS
HOMA-β**45.5 (10.3 - 155)41.7 (8.49 - 139)45.4 (8.83 - 107)NSNS
HMW adiponectin (μg/mL)3.46 (1.32 - 10.9)-3.37 (1.42 - 12.8)-0.024
LDL cholesterol (mg/dL)124 (53.0 - 154)107 (58.0 - 151)108 (50.0 - 168)0.0030.037
HDL cholesterol (mg/dL)76.5 (37.0 - 1 06)72 (45.0 - 108)71 (43.0 - 108)NS0.027
Non-HDL cholesterol (mg/dL)130 (64.0 - 167)117 (70.0 - 157)115 (58.0 - 170)0.0010.01
Triglyceride (mg/dL)86.5 (44.0 - 258)108 (42.0 - 187)110 (39.0 - 193)NSNS
baPWV (cm/s)
  Rt1,884 (1,243 - 2,545)-1,808 (1,201 - 2,972)-NS
  Lt1,867 (1,241 - 2,687)-1,836 (1,201 - 3,032)-NS
hs-CRP (ng/mL)431 (86 - 4,520)563 (148 - 7,120)468 (109 - 4,990)NSNS
Ferritin (ng/mL)96 (7.1 - 256)-90.8 (5.1 - 299)-NS
AST (IU/L)21 (13 - 43)21 (11 - 42)20 (12 - 63)NSNS
ALT (IU/L)19 (9 - 48)17 (7 - 55)19 (7 - 64)NSNS
γ-GTP(IU/L)19 (12 - 45)18 (11 - 47)19 (13 - 47)NSNS
Serum Cr (mg/dL)0.61 (0.39 - 0.82)0.61 (0.43 - 0.81)0.61 (0.39 - 0.81)NSNS
UACR (mg/g CRE)13.5 (3.7 - 42.8)-10.1 (2.1 - 80.4)-NS
Cystatin C (mg/L)0.59 (0.41 - 0.84)-0.55 (0.33 - 0.87)-0.009
Weight (kg)54.5 (42.5 - 70)54.6 (42.2 - 69)55 (42.3 - 70)NSNS