Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00679939

First received: May 15, 2008

Last updated: April 5, 2013

Last verified: April 2013

History of Changes

Results First Received: January 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: Rosiglitazone Drug: Metformin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Description

Rosiglitazone in DB Period; Metformin in OL Period

Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.

Metformin in DB Period; Metformin in OL Period

Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.

Participant Flow for 2 periods

Period 1: 52-Week Double-Blind (DB) Period

	Rosiglitazone in DB Period; Metformin in OL Period	Metformin in DB Period; Metformin in OL Period
STARTED	114	112
COMPLETED	77	85
NOT COMPLETED	37	27
Withdrew Consent	17	13
Adverse Event	14	12
Investigator Discretion	5	0
Protocol Violation	1	0
Lost to Follow-up	0	2

Period 2: 24-Week Open-Label (OL) Period

	Rosiglitazone in DB Period; Metformin in OL Period	Metformin in DB Period; Metformin in OL Period
STARTED	76 ^[1]	84 ^[1]
COMPLETED	69	80
NOT COMPLETED	7	4
Adverse Event	0	1
Protocol Violation	1	1
Met Stopping Criteria	3	1
Physician Decision	1	0
Withdrawal by Subject	2	1

[1]	One participant who completed the DB Period did not receive the OL dose of MET.

Baseline Characteristics

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Reporting Groups

	Description
Rosiglitazone in DB Period; Metformin in OL Period	Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
Metformin in DB Period; Metformin in OL Period	Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
Total	Total of all reporting groups

Baseline Measures

	Rosiglitazone in DB Period; Metformin in OL Period	Metformin in DB Period; Metformin in OL Period	Total
Number of Participants [units: participants]	114	111	225
Age ^[1] [units: Years] Mean ± Standard Deviation
Years	63.6 ± 6.61	64.0 ± 6.46	63.8 ± 6.52
Gender ^[1] [units: Participants]
Female	114	111	225
Male	0	0	0
Race/Ethnicity, Customized ^[1] [units: participants]
White – White/Caucasian/European	82	78	160
African American/African	2	8	10
American Indian or Alaskan Native	6	5	11
Asian - Central/South Asian	13	10	23
South East Asian	4	6	10
Mixed Race	3	2	5
East Asia	4	2	6

[1]	Baseline Characteristics were summarized for all participants in the Safety Population, comprised of all randomized participants who received at least one dose of study medication. One participant in the Metformin arm did not receive study medication and was not included in the Safety Population.

Outcome Measures

Show All Outcome Measures

1. Primary:

Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52 [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 1

2. Primary:

Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days [ Time Frame: Baseline and Week 76+10 days ]

Show Outcome Measure 2

3. Primary:

Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days [ Time Frame: Week 52+10 days and Week 76+10 days ]

Show Outcome Measure 3

4. Secondary:

Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 4

5. Secondary:

Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+10 Days to Week 76 + 10 Days [ Time Frame: Week 52 + 10 days and Week 76 + 10 days ]

Show Outcome Measure 5

6. Secondary:

Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 6

7. Secondary:

Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 [ Time Frame: Baseline, Week 52, and Week 76 ]

Show Outcome Measure 7

8. Secondary:

Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 [ Time Frame: Week 52 and Week 76 ]

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9. Secondary:

Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 [ Time Frame: Baseline, Week 52, and Week 76 ]

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10. Secondary:

Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76 [ Time Frame: Week 52 and Week 76 ]

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11. Secondary:

Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 [ Time Frame: Baseline, Week 52, and Week 76 ]

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12. Secondary:

Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76 [ Time Frame: Week 52 and Week 76 ]

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13. Secondary:

Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 [ Time Frame: Baseline, Week 52, and Week 76 ]

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14. Secondary:

Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76 [ Time Frame: Week 52 and Week 76 ]

Show Outcome Measure 14

15. Secondary:

Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 [ Time Frame: Baseline, Week 52, and Week 76 ]

Show Outcome Measure 15

16. Secondary:

Percent Change in Serum Estradiol From Week 52 to Week 76 [ Time Frame: Week 52 and Week 76 ]

Show Outcome Measure 16

17. Secondary:

Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 [ Time Frame: Baseline, Week 52, and Week 76 ]

Show Outcome Measure 17

18. Secondary:

Percent Change in Total Testosterone From Week 52 to Week 76 [ Time Frame: Week 52 and Week 76 ]

Show Outcome Measure 18

19. Secondary:

Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 [ Time Frame: Baseline, Week 52, and Week 76 ]

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20. Secondary:

Percent Change in Free Testosterone From Week 52 to Week 76 [ Time Frame: Week 52 and Week 76 ]

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21. Secondary:

Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 [ Time Frame: Baseline, Week 52, and Week 76 ]

Show Outcome Measure 21

22. Secondary:

Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76 [ Time Frame: Week 52 and Week 76 ]

Show Outcome Measure 22

23. Post-Hoc:

Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days [ Time Frame: Baseline, Week 52 + 10 days, and Week 76 + 10 days ]

Show Outcome Measure 23

24. Post-Hoc:

Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 24

25. Post-Hoc:

Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 25

26. Post-Hoc:

Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 26

27. Post-Hoc:

Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 27

28. Post-Hoc:

Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 28

29. Post-Hoc:

Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 29

30. Post-Hoc:

Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 30

31. Post-Hoc:

Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 31

32. Post-Hoc:

Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 32

33. Post-Hoc:

Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 33

34. Post-Hoc:

Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 34

35. Post-Hoc:

Adjusted Percent Change From Baseline in Vertebral Trabecular vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 35

36. Post-Hoc:

Adjusted Percent Change in Vertebral Trabecular vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 36

37. Post-Hoc:

Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 37

38. Post-Hoc:

Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior and Cortical vBMD Via QCT at Week 76 + 30 Days [ Time Frame: Baseline and Week 76 + 30 days ]

Show Outcome Measure 38

39. Post-Hoc:

Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 39

40. Post-Hoc:

Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 40

41. Post-Hoc:

Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 41

42. Post-Hoc:

Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days [ Time Frame: Baseline and Week 76 + 30 days ]

Show Outcome Measure 42

43. Post-Hoc:

Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 43

44. Post-Hoc:

Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 44

45. Post-Hoc:

Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 plus 30 days, and Week 76 + 30 days ]

Show Outcome Measure 45

46. Post-Hoc:

Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days [ Time Frame: Baseline and Week 76 + 30 days ]

Show Outcome Measure 46

47. Post-Hoc:

Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 47

48. Post-Hoc:

Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 48

49. Post-Hoc:

Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 49

50. Post-Hoc:

Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days [ Time Frame: Baseline and Week 76 + 30 days ]

Show Outcome Measure 50

51. Post-Hoc:

Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 51

52. Post-Hoc:

Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 52

53. Post-Hoc:

Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 53

54. Post-Hoc:

Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT at Week 76 + 30 Days [ Time Frame: Baseline and Week 76 + 30 days ]

Show Outcome Measure 54

55. Post-Hoc:

Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 55

56. Post-Hoc:

Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 56

57. Post-Hoc:

Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 57

58. Post-Hoc:

Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days [ Time Frame: Baseline and Week 76 + 30 days ]

Show Outcome Measure 58

59. Post-Hoc:

Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 59

60. Post-Hoc:

Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 60

61. Post-Hoc:

Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 61

62. Post-Hoc:

Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days [ Time Frame: Baseline and Week 76 + 30 days ]

Show Outcome Measure 62

63. Post-Hoc:

Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 63

64. Post-Hoc:

Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 64

65. Post-Hoc:

Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days [ Time Frame: Baseline, Week 52 + 30 days, and Week 76 + 30 days ]

Show Outcome Measure 65

66. Post-Hoc:

Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days [ Time Frame: Baseline and Week 76 + 30 days ]

Show Outcome Measure 66

67. Post-Hoc:

Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 67

68. Post-Hoc:

Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days [ Time Frame: Week 52 + 30 days and Week 76 + 30 days ]

Show Outcome Measure 68

69. Post-Hoc:

Adjusted Change From Baseline in Albumin-adjusted Serum Calcium (AASC) at Week 52 and Week 76 [ Time Frame: Baseline, Week 52, and Week 76 ]

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70. Post-Hoc:

Adjusted Change in Albumin-adjusted Serum Calcium (AASC) From Week 52 to Week 76 [ Time Frame: Week 52 and Week 76 ]

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71. Other Pre-specified:

Percent Change in Percentage of Free Estradiol From Week 52 to Week 76 [ Time Frame: Week 52 and Week 76 ]

Show Outcome Measure 71

72. Other Pre-specified:

Percent Change in Free Estradiol From Week 52 to Week 76 [ Time Frame: Week 52 and Week 76 ]

Show Outcome Measure 72

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Bilezikian JP, Josse RG, Eastell R, Lewiecki EM, Miller CG, Wooddell M, Northcutt AR, Kravitz BG, Paul G, Cobitz AR, Nino AJ, Fitzpatrick LA. Rosiglitazone decreases bone mineral density and increases bone turnover in postmenopausal women with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Apr;98(4):1519-28. doi: 10.1210/jc.2012-4018. Epub 2013 Feb 28.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00679939 History of Changes
Other Study ID Numbers:	AVD111179
Study First Received:	May 15, 2008
Results First Received:	January 7, 2011
Last Updated:	April 5, 2013
Health Authority:	Canada: Health Canada United States: Food and Drug Administration

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