Type 2 Diabetes MellitusPhase 4NCT00440375
Effects of Rosiglitazone on Bone in Postmenopausal Diabetic Women
A Phase 4 study testing Rosiglitazone in people with Type 2 Diabetes Mellitus and Obesity, run by Baskent University.
Trial summary
The purpose of this study is to evaluate the effect of rosiglitazone on bone metabolism and to assess the association between the changes in bone turnover parameters and plasma cytokine levels in postmenopausal diabetic women Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity, Menopause
- What is being tested?
- Rosiglitazone
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Mar 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Newly diagnosed type 2 diabetes mellitus
- Postmenopausal period
Who cannot join
- Recent fracture or osteoporosis
- Drugs that may affect calcium or bone metabolism or drugs known to interfere with cytokine release
- Thyroid, parathyroid, pituitary, nutritional, inflammatory, hepatic, renal, or neoplastic disorders
- Severe cardiovascular disease
About this study
The purpose of this study is to evaluate the effect of rosiglitazone on bone metabolism and to assess the association between the changes in bone turnover parameters and plasma cytokine levels in postmenopausal diabetic women
Read the detailed description
Fifty-six obese, drug naive patients with type 2 diabetes mellitus were enrolled and completed the study. Twenty-six healthy subjects matched for age and body mass index (BMI) served as nondiabetic controls. All subjects were postmenopausal women with last menses at least 2 years. After the baseline measurements, all subjects were instructed to follow a weight-maintaining diet, based on ADA recommendations, and were also encouraged to walk or to jog at least 30 min daily. Subsequently, 28 of the diabetic subjects were randomly assigned to receive rosiglitazone (4 mg/day). Twenty-eight of diabetic subjects were on diet alone. The randomization procedure was based on a random sequence.
All subjects had a complete clinical examination, anthropometric measurements, and laboratory tests at baseline and at the end of the 12th week of the study. Laboratory investigations included assessment of: (i) glycemic control (HbA1c, fasting plasma glucose and insulin levels, and homeostasis model assessment (HOMA) index (22); (ii) serum bsALP and active human osteocalcin concentration (OCL) as markers of bone formation; (iii) urine deoxypyridinoline (DPD) as marker of bone resorption. Other non-specific bone markers including serum total ALP activity, urinary calcium (Ca) and phosphate (PO4) concentrations were also measured. Urine concentrations of DPD (nmol/L), Ca and PO4 (both in mmol/L) were corrected for their respective urine creatinine (Cr) concentrations in mmol/L (Urine DPD/Cr, Urine Ca/Cr and Urine PO4/Cr respectively). In addition, fasting blood samples were analyzed for plasma cytokine levels including IL-1β, IL-6 and TNF-α, and for haptoglobin levels.
- Conditions
- Type 2 Diabetes Mellitus, Obesity, Menopause
- Being tested
- Rosiglitazone
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic bone markers before and after the intervention,
Secondary outcomes (1)
association between the changes in bone turnover parameters and plasma cytokine levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startJun 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Investigators
- Zehra Berberoglu, Principal investigator, The Society of Endocrinology and Metabolism of Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440375
- Sponsor's protocol ID
- KA 05/74
- Status last verified
- Feb 2007
- First submitted
- 26 Feb 2007
- Last updated
- 27 Feb 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berberoglu Z, Gursoy A, Bayraktar N, Yazici AC, Bascil Tutuncu N, Guvener Demirag N. Rosiglitazone decreases serum bone-specific alkaline phosphatase activity in postmenopausal diabetic women. J Clin Endocrinol Metab. 2007 Sep;92(9):3523-30. doi: 10.1210/jc.2007-0431. Epub 2007 Jun 26.
PubMed 17595249
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rosiglitazone on Bone in Postmenopausal Diabetic Women
- ClinicalTrials.gov ID
- NCT00440375
- Acronym / sponsor ID
- KA 05/74
- Conditions
- Type 2 Diabetes Mellitus, Obesity, Menopause
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Mar 2006
- First posted
- 27 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of rosiglitazone on bone metabolism and to assess the association between the changes in bone turnover parameters and plasma cytokine levels in postmenopausal diabetic women
Detailed description
Fifty-six obese, drug naive patients with type 2 diabetes mellitus were enrolled and completed the study. Twenty-six healthy subjects matched for age and body mass index (BMI) served as nondiabetic controls. All subjects were postmenopausal women with last menses at least 2 years. After the baseline measurements, all subjects were instructed to follow a weight-maintaining diet, based on ADA recommendations, and were also encouraged to walk or to jog at least 30 min daily. Subsequently, 28 of the diabetic subjects were randomly assigned to receive rosiglitazone (4 mg/day). Twenty-eight of diabetic subjects were on diet alone. The randomization procedure was based on a random sequence.
All subjects had a complete clinical examination, anthropometric measurements, and laboratory tests at baseline and at the end of the 12th week of the study. Laboratory investigations included assessment of: (i) glycemic control (HbA1c, fasting plasma glucose and insulin levels, and homeostasis model assessment (HOMA) index (22); (ii) serum bsALP and active human osteocalcin concentration (OCL) as markers of bone formation; (iii) urine deoxypyridinoline (DPD) as marker of bone resorption. Other non-specific bone markers including serum total ALP activity, urinary calcium (Ca) and phosphate (PO4) concentrations were also measured. Urine concentrations of DPD (nmol/L), Ca and PO4 (both in mmol/L) were corrected for their respective urine creatinine (Cr) concentrations in mmol/L (Urine DPD/Cr, Urine Ca/Cr and Urine PO4/Cr respectively). In addition, fasting blood samples were analyzed for plasma cytokine levels including IL-1β, IL-6 and TNF-α, and for haptoglobin levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed type 2 diabetes mellitus
- Postmenopausal period
Key exclusion criteria (4 listed)
- Recent fracture or osteoporosis
- Drugs that may affect calcium or bone metabolism or drugs known to interfere with cytokine release
- Thyroid, parathyroid, pituitary, nutritional, inflammatory, hepatic, renal, or neoplastic disorders
- Severe cardiovascular disease
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 |
|---|---|---|
| Rosiglitazone | Drug | – |
Primary outcome
metabolic bone markers before and after the intervention,
1 secondary outcome
association between the changes in bone turnover parameters and plasma cytokine levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2007.
- Derived from this study: PubMed 17595249Berberoglu Z, Gursoy A, Bayraktar N, Yazici AC, Bascil Tutuncu N, Guvener Demirag N. Rosiglitazone decreases serum bone-specific alkaline phosphatase activity in postmenopausal diabetic women. J Clin Endocrinol Metab. 2007 Sep;92(9):3523-30. doi: 10.1210/jc.2007-0431. Epub 2007 Jun 26.
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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.
Zehra Berberoglu principal investigator
The Society of Endocrinology and Metabolism of Turkey
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosiglitazone in people with Type 2 Diabetes Mellitus and Obesity, run by Baskent University.
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 2 inclusion and 4 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 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
metabolic bone markers before and after the intervention,. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00440375, which also lists 1 linked publication.
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 Feb 2007.