Change in Bone Mineral DensityPhase 2NCT00609362
The Effect of Glitazone Treatment on Bone Marrow and Bone Marrow Cells
A Phase 2 study testing Rosiglitazone in people with Change in Bone Mineral Density and Change in Bone Marrow Fat Content, run by University of Aarhus at 1 site in Denmark.
Trial summary
Osteoporosis is a generalised bone disease leading to an increased risk of fractures. The disease is caused partly by environmental and partly by genetic factors. It is well known that the fat content of the bone marrow is increased in osteoporotic patients. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Change in Bone Mineral Density, Change in Bone Marrow Fat Content
- What is being tested?
- Rosiglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Nov 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women age 60-75 with no rosiglitazone allergy
Who cannot join
- Osteoporosis
- Diabetes
- Hyperthyroidism, untreated hypothyroidism, hyperparathyroidism
- Treatment with bone active drugs
- Low impact fracture
- Heart disease
Show all 11Show fewer
- Kidney failure
- Liver failure
- Anaemia
- Ineligibility for MRI-scan
- Cancer within last 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Osteoporosis is a generalised bone disease leading to an increased risk of fractures. The disease is caused partly by environmental and partly by genetic factors. It is well known that the fat content of the bone marrow is increased in osteoporotic patients. Animal studies suggest that stimulation of bone marrow stem cells through the molecule PPARgamma with the drug rosiglitazone converts the stem cells to fat cells instead of bone cells thereby decreasing bone strength. In a single study healthy volunteers were treated with rosiglitazone for 14 weeks and had a decrease in bone mineral density.
In the present study we wish to investigate the effect of this treatment on bone and fat tissue. 25 women above the age of 60 will be treated with rosiglitazone 8 mg/day for 14 weeks and compared with 25 women receiving placebo.
Read more
The effect will be evaluated as follows:
- The effect on bone marrow density will be examined by a bone scan prior to and after treatment and again after 6 and 9 months.
- The effect on bone turnover will be measured in blood- and urine samples at the same times.
- The effect on fat distribution will be evaluated by an MRI scan after treatment.
- The effect on bone marrow cells will be investigated bone marrow sampling immediately after treatment
- The direct effect on fat will be examined by a biopsy immediately after treatment The study hypothesis is that rosiglitazone treatment decreases bone mineral density and increases bone marrow fat content. The causal molecular mechanisms will be investigated from the bone marrow and fat samples
- Being tested
- Rosiglitazone, Placebo pill
- Keywords
- BMD, Rosiglitazone, Bone marrow fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
Also called Avandia
one tablet of rosiglitazone 8 milligrams per day for 14 weeks
Placebo pillDrug
One encapsulated placebo pill a day for 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rosiglitazone | Active comparator | 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day Receives: Drug: Rosiglitazone |
| Placebo | Placebo comparator | 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks Receives: Drug: Placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Percent Change in Bone Mineral Density (BMD) From Baseline to 14 Weeks Between the Rosiglitazone Group and the Placebo Group
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)
Measured: BMD measured at baseline and after 14 weeks of treatment
Secondary outcomes (3)
Difference in Percent Change in Bone Marrow Fat (Given by a Lipid to Water Ratio) in the Spine.
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)
Measured: Measured at baseline and after 14 weeks of treatment
Difference in Percent Change in Level of C-terminal Telopeptide (CTx) Between the Rosiglitazone and Placebo Groups
C-terminal telopeptide is a marker of bone resorption. Its levels are measure in plasma using a chemiluminometric method (ECLIA).
Measured: At baseline and after 14 weeks of treatment
Change in Gene Expression in Bone Marrow and Fat Cells
Measured: Before and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Change in Bone Mineral DensityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Torben Harsløf, Dr., Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609362
- Sponsor's protocol ID
- 2007-223
- Status last verified
- Mar 2011
- First submitted
- 24 Jan 2008
- Last updated
- 27 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glitazone Treatment on Bone Marrow and Bone Marrow Cells
- ClinicalTrials.gov ID
- NCT00609362
- Acronym / sponsor ID
- 2007-223
- Keywords
- BMD, Rosiglitazone, Bone marrow fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Posted 27 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoporosis is a generalised bone disease leading to an increased risk of fractures. The disease is caused partly by environmental and partly by genetic factors. It is well known that the fat content of the bone marrow is increased in osteoporotic patients. Animal studies suggest that stimulation of bone marrow stem cells through the molecule PPARgamma with the drug rosiglitazone converts the stem cells to fat cells instead of bone cells thereby decreasing bone strength. In a single study healthy volunteers were treated with rosiglitazone for 14 weeks and had a decrease in bone mineral density.
In the present study we wish to investigate the effect of this treatment on bone and fat tissue. 25 women above the age of 60 will be treated with rosiglitazone 8 mg/day for 14 weeks and compared with 25 women receiving placebo.
The effect will be evaluated as follows:
- The effect on bone marrow density will be examined by a bone scan prior to and after treatment and again after 6 and 9 months.
- The effect on bone turnover will be measured in blood- and urine samples at the same times.
- The effect on fat distribution will be evaluated by an MRI scan after treatment.
- The effect on bone marrow cells will be investigated bone marrow sampling immediately after treatment
- The direct effect on fat will be examined by a biopsy immediately after treatment The study hypothesis is that rosiglitazone treatment decreases bone mineral density and increases bone marrow fat content. The causal molecular mechanisms will be investigated from the bone marrow and fat samples
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosiglitazone | Active comparator | Drug: Rosiglitazone25 women age 60 to 75 years receiving rosiglitazone 8 mg/day |
| Placebo | Placebo comparator | Drug: Placebo pill25 women 60 to 75 years of age receiving placebo once a day for 14 weeks |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women age 60-75 with no rosiglitazone allergy
Key exclusion criteria (11 listed)
- Osteoporosis
- Diabetes
- Hyperthyroidism, untreated hypothyroidism, hyperparathyroidism
- Treatment with bone active drugs
- Low impact fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosiglitazoneAlso: Avandiaone tablet of rosiglitazone 8 milligrams per day for 14 weeks | Drug | Rosiglitazone |
| Placebo pillOne encapsulated placebo pill a day for 14 weeks | Drug | Placebo |
Primary outcome
Difference in Percent Change in Bone Mineral Density (BMD) From Baseline to 14 Weeks Between the Rosiglitazone Group and the Placebo Group
Time frame: 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)
3 secondary outcomes
Difference in Percent Change in Bone Marrow Fat (Given by a Lipid to Water Ratio) in the Spine.
Time frame: Measured at baseline and after 14 weeks of treatment
Difference in Percent Change in Level of C-terminal Telopeptide (CTx) Between the Rosiglitazone and Placebo Groups
Time frame: At baseline and after 14 weeks of treatment
Change in Gene Expression in Bone Marrow and Fat Cells
Time frame: Before and after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torben Harsløf, Dr. principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rosiglitazone in people with Change in Bone Mineral Density and Change in Bone Marrow Fat Content, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Percent Change in Bone Mineral Density (BMD) From Baseline to 14 Weeks Between the Rosiglitazone Group and the Placebo Group (time frame: BMD measured at baseline and after 14 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2011.