Trial Outcomes & Findings for The Effect of Glitazone Treatment on Bone Marrow and Bone Marrow Cells (NCT NCT00609362)

Results Overview

Difference in percent change in bone mineral density (BMD) from baseline to 14 weeks between the rosiglitazone group and the placebo group. BMD was assesed using dual x-ray absorptiometry (DXA)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

57 participants

Primary outcome timeframe

BMD measured at baseline and after 14 weeks of treatment

Results posted on

2011-04-27

Participant Flow

Recruitment commenced january 2008 and ended february 2009. Participants were recruited by ads in local papers and called our osteoporosis clinic. 179 called and after a course description 150 were sent information. After having read that 74 paid a visit to the clinic.

74 individuals were screened. 17 were screen failures due to exclusion criteria. 57 were randomized.

Participant milestones

Participant milestones
Measure	Rosiglitazone 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day	Placebo 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
Overall Study STARTED	29	28
Overall Study COMPLETED	26	27
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Rosiglitazone 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day	Placebo 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
Overall Study Withdrawal by Subject	2	1
Overall Study Adverse Event	1	0

Baseline Characteristics

The Effect of Glitazone Treatment on Bone Marrow and Bone Marrow Cells

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rosiglitazone n=29 Participants 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day	Placebo n=28 Participants 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Age Continuous	65.1 years STANDARD_DEVIATION 3.5 • n=5 Participants	65.3 years STANDARD_DEVIATION 4.3 • n=7 Participants	65.2 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Denmark	29 participants n=5 Participants	28 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: BMD measured at baseline and after 14 weeks of treatment

Difference in percent change in bone mineral density (BMD) from baseline to 14 weeks between the rosiglitazone group and the placebo group. BMD was assesed using dual x-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Rosiglitazone n=29 Participants 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day	Placebo n=28 Participants 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
Difference in Percent Change in Bone Mineral Density (BMD) From Baseline to 14 Weeks Between the Rosiglitazone Group and the Placebo Group	-1.3 Percent change from baseline Standard Deviation 3.1	0.3 Percent change from baseline Standard Deviation 2.9

SECONDARY outcome

Timeframe: Measured at baseline and after 14 weeks of treatment

Bone marrow fat was measured using MRI spectroscopy providing a measure of bone marrow fat as a ratio to bone marrow water, the lipid-water ratio (LWR)

Outcome measures

Outcome measures
Measure	Rosiglitazone n=29 Participants 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day	Placebo n=28 Participants 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
Difference in Percent Change in Bone Marrow Fat (Given by a Lipid to Water Ratio) in the Spine.	-13.5 Percent change in LWR Standard Deviation 5.5	6.8 Percent change in LWR Standard Deviation 24.4

SECONDARY outcome

Timeframe: At baseline and after 14 weeks of treatment

C-terminal telopeptide is a marker of bone resorption. Its levels are measure in plasma using a chemiluminometric method (ECLIA).

Outcome measures

Outcome measures
Measure	Rosiglitazone n=29 Participants 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day	Placebo n=28 Participants 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
Difference in Percent Change in Level of C-terminal Telopeptide (CTx) Between the Rosiglitazone and Placebo Groups	20.4 Percent change from baseline Standard Deviation 38.6	-7.1 Percent change from baseline Standard Deviation 24.4

SECONDARY outcome

Timeframe: Before and after treatment

Outcome measures

Outcome data not reported

Adverse Events

Rosiglitazone

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rosiglitazone n=26 participants at risk 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day	Placebo n=27 participants at risk 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
Respiratory, thoracic and mediastinal disorders Cold	15.4% 4/26 • Number of events 4	7.4% 2/27 • Number of events 2
Gastrointestinal disorders Diarrhea	3.8% 1/26 • Number of events 1	7.4% 2/27 • Number of events 2
Musculoskeletal and connective tissue disorders Fall	0.00% 0/26	7.4% 2/27 • Number of events 3
Nervous system disorders Headache	23.1% 6/26 • Number of events 7	14.8% 4/27 • Number of events 4
Metabolism and nutrition disorders Hypercholesterolemia	15.4% 4/26 • Number of events 4	7.4% 2/27 • Number of events 2
Musculoskeletal and connective tissue disorders Tendinitis	7.7% 2/26 • Number of events 2	3.7% 1/27 • Number of events 1
Cardiac disorders Edema	23.1% 6/26 • Number of events 6	7.4% 2/27 • Number of events 2

Additional Information

Torben Harsløf, MD

University of Aarhus

Phone: +4589497681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place