Trial Outcomes & Findings for Effect of Diabetic Medications on Bone Metabolism (NCT NCT00467285)
NCT ID: NCT00467285
Last Updated: 2015-01-14
Results Overview
% changes in BMD ( BMD at Lumbar spine, femoral neck and 0.33 radius) and bone turn over markers in subjects with diabetes on pioglitazone compared to those who are not on Pioglitazone
Recruitment status
COMPLETED
Target enrollment
96 participants
Primary outcome timeframe
6 months
Results posted on
2015-01-14
Participant Flow
Endo-Research clinic
Young male veterans with type 2 diabetes with creatinine less than 1.4, aged less than 55 years
Participant milestones
| Measure |
Group 1
32 subjects with type 2 diabetes on pioglitazone.
|
Group 2
64 subjects with type 2 diabetes not on pioglitazone, less than 55 years old.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
64
|
|
Overall Study
COMPLETED
|
28
|
60
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Group 1
32 subjects with type 2 diabetes on pioglitazone.
|
Group 2
64 subjects with type 2 diabetes not on pioglitazone, less than 55 years old.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
Effect of Diabetic Medications on Bone Metabolism
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=32 Participants
32 subjects with type 2 diabetes on pioglitazone.
|
No Pioglitazone
n=64 Participants
64 subjects with type 2 diabetes not on pioglitazone, less than 55 years old.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 2 • n=99 Participants
|
49 years
STANDARD_DEVIATION 2 • n=107 Participants
|
49 years
STANDARD_DEVIATION 2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Ctx
|
29 pg/mL
STANDARD_DEVIATION 2 • n=99 Participants
|
19 pg/mL
STANDARD_DEVIATION 3 • n=107 Participants
|
22 pg/mL
STANDARD_DEVIATION 3 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 28 subjects on pioglitazone and 64 subjects not on pioglitazone
% changes in BMD ( BMD at Lumbar spine, femoral neck and 0.33 radius) and bone turn over markers in subjects with diabetes on pioglitazone compared to those who are not on Pioglitazone
Outcome measures
| Measure |
No Pioglitazone
n=64 Participants
64 subjects with type 2 diabetes not on pioglitazone
|
Baseline Characteristics: Group 1
n=28 Participants
Mean age of 49 with mean BMI 0f 33.6 ± 5; HbA1C of 7.54
|
|---|---|---|
|
Changes in BMD at Femoral Neck
|
0.25 percentage of change in BMD
Standard Deviation 0.24
|
-3.2 percentage of change in BMD
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: 6 months% change at 6 month follow up compared to baseline
Outcome measures
| Measure |
No Pioglitazone
n=64 Participants
64 subjects with type 2 diabetes not on pioglitazone
|
Baseline Characteristics: Group 1
n=28 Participants
Mean age of 49 with mean BMI 0f 33.6 ± 5; HbA1C of 7.54
|
|---|---|---|
|
Changes in BMD Total Hip
|
-0.2 % change in BMD
Standard Deviation 0.21
|
-3.5 % change in BMD
Standard Deviation 0.24
|
PRIMARY outcome
Timeframe: 6 months% change in BMD at 6 month follow up compared to baseline
Outcome measures
| Measure |
No Pioglitazone
n=64 Participants
64 subjects with type 2 diabetes not on pioglitazone
|
Baseline Characteristics: Group 1
n=28 Participants
Mean age of 49 with mean BMI 0f 33.6 ± 5; HbA1C of 7.54
|
|---|---|---|
|
Changes in BMD AP Spine
|
0.89 % change in BMD
Standard Deviation 0.1
|
-0.1 % change in BMD
Standard Deviation 0.04
|
PRIMARY outcome
Timeframe: 6 months% change in BMD at 6 month follow up compared to baseline
Outcome measures
| Measure |
No Pioglitazone
n=64 Participants
64 subjects with type 2 diabetes not on pioglitazone
|
Baseline Characteristics: Group 1
n=28 Participants
Mean age of 49 with mean BMI 0f 33.6 ± 5; HbA1C of 7.54
|
|---|---|---|
|
Changes in BMD 0.33 Radius
|
-0.21 % change in BMD
Standard Deviation 0.4
|
-3.8 % change in BMD
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: 6 months% Change in bone turnover markers at 6 month follow up compared to baseline
Outcome measures
| Measure |
No Pioglitazone
n=64 Participants
64 subjects with type 2 diabetes not on pioglitazone
|
Baseline Characteristics: Group 1
n=28 Participants
Mean age of 49 with mean BMI 0f 33.6 ± 5; HbA1C of 7.54
|
|---|---|---|
|
CTx
|
4.8 pg/mL
Standard Deviation 1.28
|
4.9 pg/mL
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 6 months% change at 6 month follow up compared to baseline
Outcome measures
| Measure |
No Pioglitazone
n=64 Participants
64 subjects with type 2 diabetes not on pioglitazone
|
Baseline Characteristics: Group 1
n=28 Participants
Mean age of 49 with mean BMI 0f 33.6 ± 5; HbA1C of 7.54
|
|---|---|---|
|
Osteocalcin
|
-12.44 % change
Standard Deviation 2
|
-20.49 % change
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 6 months% change in the levels of CTx at 6 months follow up compared to baseline
Outcome measures
| Measure |
No Pioglitazone
n=64 Participants
64 subjects with type 2 diabetes not on pioglitazone
|
Baseline Characteristics: Group 1
n=28 Participants
Mean age of 49 with mean BMI 0f 33.6 ± 5; HbA1C of 7.54
|
|---|---|---|
|
Changes in CTx at Follow up
|
19 % change
Standard Deviation 3
|
29 % change
Standard Deviation 2
|
Adverse Events
Pioglitazone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Pioglitazone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place