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=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=93 Participants	64 Participants n=4 Participants	96 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	49 years STANDARD_DEVIATION 2 • n=93 Participants	49 years STANDARD_DEVIATION 2 • n=4 Participants	49 years STANDARD_DEVIATION 2 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	32 Participants n=93 Participants	64 Participants n=4 Participants	96 Participants n=27 Participants
Ctx	29 pg/mL STANDARD_DEVIATION 2 • n=93 Participants	19 pg/mL STANDARD_DEVIATION 3 • n=4 Participants	22 pg/mL STANDARD_DEVIATION 3 • n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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	Piogliazone n=28 Participants 32 Subjects with type 2 diabetes on Pioglitazone	No Pioglitazone n=64 Participants 64 subjects with type 2 diabetes not on pioglitazone
Changes in BMD at Femoral Neck	-3.2 percentage of change in BMD Standard Deviation 0.25	0.25 percentage of change in BMD Standard Deviation 0.24

PRIMARY outcome

Timeframe: 6 months

% change at 6 month follow up compared to baseline

Outcome measures

Measure	Piogliazone n=28 Participants 32 Subjects with type 2 diabetes on Pioglitazone	No Pioglitazone n=64 Participants 64 subjects with type 2 diabetes not on pioglitazone
Changes in BMD Total Hip	-3.5 % change in BMD Standard Deviation 0.24	-0.2 % change in BMD Standard Deviation 0.21

PRIMARY outcome

Timeframe: 6 months

% change in BMD at 6 month follow up compared to baseline

Outcome measures

Measure	Piogliazone n=28 Participants 32 Subjects with type 2 diabetes on Pioglitazone	No Pioglitazone n=64 Participants 64 subjects with type 2 diabetes not on pioglitazone
Changes in BMD AP Spine	-0.1 % change in BMD Standard Deviation 0.04	0.89 % change in BMD Standard Deviation 0.1

PRIMARY outcome

Timeframe: 6 months

% change in BMD at 6 month follow up compared to baseline

Outcome measures

Measure	Piogliazone n=28 Participants 32 Subjects with type 2 diabetes on Pioglitazone	No Pioglitazone n=64 Participants 64 subjects with type 2 diabetes not on pioglitazone
Changes in BMD 0.33 Radius	-3.8 % change in BMD Standard Deviation 0.22	-0.21 % change in BMD Standard Deviation 0.4

SECONDARY outcome

Timeframe: 6 months

% Change in bone turnover markers at 6 month follow up compared to baseline

Outcome measures

Measure	Piogliazone n=28 Participants 32 Subjects with type 2 diabetes on Pioglitazone	No Pioglitazone n=64 Participants 64 subjects with type 2 diabetes not on pioglitazone
CTx	4.9 pg/mL Standard Deviation 2.1	4.8 pg/mL Standard Deviation 1.28

SECONDARY outcome

Timeframe: 6 months

% change at 6 month follow up compared to baseline

Outcome measures

Measure	Piogliazone n=28 Participants 32 Subjects with type 2 diabetes on Pioglitazone	No Pioglitazone n=64 Participants 64 subjects with type 2 diabetes not on pioglitazone
Osteocalcin	-20.49 % change Standard Deviation 2.5	-12.44 % change Standard Deviation 2

SECONDARY outcome

Timeframe: 6 months

% change in the levels of CTx at 6 months follow up compared to baseline

Outcome measures

Measure	Piogliazone n=28 Participants 32 Subjects with type 2 diabetes on Pioglitazone	No Pioglitazone n=64 Participants 64 subjects with type 2 diabetes not on pioglitazone
Changes in CTx at Follow up	29 % change Standard Deviation 2	19 % change Standard Deviation 3

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

Dr. Subhashini Yaturu

Samuel Stratton VAMC

Phone: 518-626-5642

Email: Subhashini.Yaturu@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place