OsteoporosisPhase 4NCT02429232
A One-year Randomized Controlled Trial Evaluating the Impact of Pioglitazone Versus Linagliptin on Bone Turnover Markers
A Phase 4 study testing Pioglitazone and Linagliptin in people with Osteoporosis and Diabetes Mellitus, run by National Taiwan University Hospital.
Trial summary
Diabetes mellitus is a common disease with much impact on human's health and is related to osteoporosis. But the mechanism remains unclear. The foreign researches revealed thiazolidinedione (TZD) would increase the risk of osteoporosis and bone fracture, specially elderly women. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoporosis, Diabetes Mellitus
- What is being tested?
- Pioglitazone and Linagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Males or females ≥ 40 years of age at Visit 1and females in postmenopause for one year
- Documentation of type 2 diabetes mellitus as evidenced by one or more of the following criteria:
- With typical symptoms and random blood sugar ≥ 200 mg/dl
- 8-hour fasting blood sugar ≥ 126 mg/dl
- Oral glucose tolerance test ≥ 200 mg/dl
- HbA1c≥ 6.5%
- Only receiving oral anti-diabetic drugs (excluding TZDs or DPP-4 inhibitors) till visit 1 at least 3 months, and the HbA1c is between 7.0~8.5 % in recent 3 months.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Who cannot join
- DM on oral anti-diabetic drugs less than 3 months.
- Receiving treatment of TZDs or DPP-4 inhibitors prior to this study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- AST, ALT over 2.5 times of the upper limit.
- Chronic kidney disease, stage 4 and 5.
- Congestive heart failure, NYHA class III, IV
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- History of osteoporosis.
- History of diseases known to affect bone metabolism:
- Abnormal thyroid function or history of hyperthyroidism, Cushing's syndrome, hypogonadism, acromegaly, history of hypopituitarism or status post pituitary surgery and/or radiotherapy, hematopoietic disorders.
- History of moderate to severe Diabetic macular edema (DME)
- History of moderate to severe diabetic retinopathy.
- History of fracture over lumbar spine or hip joint or femoral head or forearm or any site of bone fracture undergoes treatment currently.
- Who had taken any of the following medications prior to screening:
- Corticosteroid, heparin, anticonvulsants, aluminum-containing antacid, proton pump inhibitor, immunosuppressant user within 3 months. Bisphosphonate, systemic fluoride treatment, PHT analogue, calcitonin, Denosumab, Strontium ranelate, hormone replacement therapy (androgen/estrogen/progesterone, thyroxine, growth hormone), selective estrogen receptor modulator /SERM (Tamoxifene, Raloxifene), selective tissue estrogenic activity regulator /STEAR (Tibolone), aromatase inhibitors within 1 year.
- History of cancer.
- Bed-ridden patients.
Trial locations and contacts
No sites are listed yet.
About this study
Diabetes mellitus is a common disease with much impact on human's health and is related to osteoporosis. But the mechanism remains unclear. The foreign researches revealed thiazolidinedione (TZD) would increase the risk of osteoporosis and bone fracture, specially elderly women. However, it is still controversial in terms of the youth and men. In Taiwan,there is few related study to analyze the relationship between TZD and steoporosis.
This is a multicenter randomized controlled study.
Read the detailed description
Diabetes mellitus is a common disease with much impact on human's health and is related to osteoporosis. But the mechanism remains unclear. The foreign researches revealed thiazolidinedione (TZD) would increase the risk of osteoporosis and bone fracture, especially elderly women. However, it is still controversial in terms of the youth and men. In Taiwan, there is few related study to analyze the relationship between TZD and osteoporosis.
This is a multicenter randomized controlled study.This study will recruit adult (age ³40 years) type 2 diabetes patients who is on metformin (³1500mg/day) currently with recent HbA1c between 7.0~8.5%.Patient who has history of macular edema, congestive heart failure (NYHA Fc III, IV), chronic renal failure (stage IV, V), AST or ALT above 2.5 times upper limit, Medical history of endocrinopathies, osteoporosis with bone fracture, cancer will be excluded. Current bone fracture undergoing treatment, pregnancy, breast feeder will also be excluded.
This is a 3-year project and will enroll 160 eligible volunteers who are to randomized into group A and B (80 in each). During the next 48 weeks group A and B will receive metformin+pioglitazone and metformin+linagliptin respectively. Blood sugar, renal, and liver functions will be examined every 12 weeks. Calcium, phosphorus, vitamin D level, and bone turnover markers (N-terminal propeptide of type 1 procollagen, bone-specific alkaline phosphatase, osteocalcin, serum C- telopeptide, type 5 tartrate resistant acid phosphatase (TRAP), pyridinoline and deoxypyridinoline crosslinks) will be checked each 6 months.
All the blood samples will be sent to one core laboratory center. The within-group differences will be examined by repeated-measure ANOVA. The between-group differences will be examined by Student's t test.
- Conditions
- Osteoporosis, Diabetes Mellitus
- Being tested
- Pioglitazone, Linagliptin
- Keywords
- Pioglitazone, Linagliptin, Diabetes mellitus, Diabetic macular edema, Kidney
- Medical subject headings
- Osteoporosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos
Pioglitazone 30mg/tablet once daily
LinagliptinDrug
Also called Trajenta
Linagliptin 5mg/tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Experimental | Pioglitazone 30 mg once daily will be administered orally for total 48 weeks. Receives: Drug: Pioglitazone |
| Linagliptin | Active comparator | Linagliptin 5 mg once daily will be administered orally for total 48 weeks. Receives: Drug: Linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in bone turnover markers
The primary objective is to assess the effect of TZD on skeleton as measured bone turnover markers over the 12 months treatment period.
Measured: Screen, Week 24, 48
Secondary outcomes (4)
Change from baseline in Estimated glomerular filtration rate( eGFR)
The objective is to assess the effect of TZD on kidney by measurement of Estimated glomerular filtration rate( eGFR) over the 12 months treatment period.
Measured: Screen, Week 24, 48
Change from baseline in renal function-serum Creatinine (Cr) level
The secondary objective is to assess the effect of TZD on kidney by measurement of doubling time of serum Creatinine (Cr) level and urine biomarkers over the 12 months treatment period.
Measured: Screen, Week 24, 48
Change from baseline in renal function-Urine Albumin-to-Creatinine Ratio(UACR)
The secondary objective is to assess the effect of TZD on kidney by measurement of doubling time of Urine Albumin-to-Creatinine Ratio(UACR) and urine biomarkers over the 12 months treatment period.
Measured: Screen, Week 24, 48
Change from baseline in urine biomarkers
The secondary objective is to assess the effect of TZD on kidney by measurement of urine biomarkers over the 12 months treatment period.
Measured: Screen, Week 24, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin-Hsiao Tseng, MD, PhD, Principal investigator, Department of Medicine,National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429232
- Sponsor's protocol ID
- 201312136MIND
- Status last verified
- Oct 2015
- First submitted
- 7 Apr 2015
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One-year Randomized Controlled Trial Evaluating the Impact of Pioglitazone Versus Linagliptin on Bone Turnover Markers
- ClinicalTrials.gov ID
- NCT02429232
- Acronym / sponsor ID
- 201312136MIND
- Conditions
- Osteoporosis, Diabetes Mellitus
- Keywords
- Pioglitazone, Linagliptin, Diabetes mellitus, Diabetic macular edema, Kidney
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Apr 2015 (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.
Diabetes mellitus is a common disease with much impact on human's health and is related to osteoporosis. But the mechanism remains unclear. The foreign researches revealed thiazolidinedione (TZD) would increase the risk of osteoporosis and bone fracture, specially elderly women. However, it is still controversial in terms of the youth and men. In Taiwan,there is few related study to analyze the relationship between TZD and steoporosis.
This is a multicenter randomized controlled study.
Detailed description
Diabetes mellitus is a common disease with much impact on human's health and is related to osteoporosis. But the mechanism remains unclear. The foreign researches revealed thiazolidinedione (TZD) would increase the risk of osteoporosis and bone fracture, especially elderly women. However, it is still controversial in terms of the youth and men. In Taiwan, there is few related study to analyze the relationship between TZD and osteoporosis.
This is a multicenter randomized controlled study.This study will recruit adult (age ³40 years) type 2 diabetes patients who is on metformin (³1500mg/day) currently with recent HbA1c between 7.0~8.5%.Patient who has history of macular edema, congestive heart failure (NYHA Fc III, IV), chronic renal failure (stage IV, V), AST or ALT above 2.5 times upper limit, Medical history of endocrinopathies, osteoporosis with bone fracture, cancer will be excluded. Current bone fracture undergoing treatment, pregnancy, breast feeder will also be excluded.
This is a 3-year project and will enroll 160 eligible volunteers who are to randomized into group A and B (80 in each). During the next 48 weeks group A and B will receive metformin+pioglitazone and metformin+linagliptin respectively. Blood sugar, renal, and liver functions will be examined every 12 weeks. Calcium, phosphorus, vitamin D level, and bone turnover markers (N-terminal propeptide of type 1 procollagen, bone-specific alkaline phosphatase, osteocalcin, serum C- telopeptide, type 5 tartrate resistant acid phosphatase (TRAP), pyridinoline and deoxypyridinoline crosslinks) will be checked each 6 months.
All the blood samples will be sent to one core laboratory center. The within-group differences will be examined by repeated-measure ANOVA. The between-group differences will be examined by Student's t test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Experimental | Drug: PioglitazonePioglitazone 30 mg once daily will be administered orally for total 48 weeks. |
| Linagliptin | Active comparator | Drug: LinagliptinLinagliptin 5 mg once daily will be administered orally for total 48 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Males or females ≥ 40 years of age at Visit 1and females in postmenopause for one year
- Documentation of type 2 diabetes mellitus as evidenced by one or more of the following criteria:
- Only receiving oral anti-diabetic drugs (excluding TZDs or DPP-4 inhibitors) till visit 1 at least 3 months, and the HbA1c is between 7.0~8.5 % in recent 3 months.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Key exclusion criteria (16 listed)
- DM on oral anti-diabetic drugs less than 3 months.
- Receiving treatment of TZDs or DPP-4 inhibitors prior to this study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- AST, ALT over 2.5 times of the upper limit.
- Chronic kidney disease, stage 4 and 5.
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 |
|---|---|---|
| PioglitazoneAlso: ActosPioglitazone 30mg/tablet once daily | Drug | Pioglitazone |
| LinagliptinAlso: TrajentaLinagliptin 5mg/tablet once daily | Drug | Linagliptin |
Primary outcome
Change from baseline in bone turnover markers
Time frame: Screen, Week 24, 48
The primary objective is to assess the effect of TZD on skeleton as measured bone turnover markers over the 12 months treatment period.
4 secondary outcomes
Change from baseline in Estimated glomerular filtration rate( eGFR)
Time frame: Screen, Week 24, 48
Change from baseline in renal function-serum Creatinine (Cr) level
Time frame: Screen, Week 24, 48
Change from baseline in renal function-Urine Albumin-to-Creatinine Ratio(UACR)
Time frame: Screen, Week 24, 48
Change from baseline in urine biomarkers
Time frame: Screen, Week 24, 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
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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.
Chin-Hsiao Tseng, MD, PhD principal investigator
Department of Medicine,National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pioglitazone and Linagliptin in people with Osteoporosis and Diabetes Mellitus, run by National Taiwan University Hospital.
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 8 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 27 Oct 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng-Jung Nien, MD (886-2-23123456 ext. 66046, fj.nien@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in bone turnover markers (time frame: Screen, Week 24, 48). 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 Oct 2015.