The Effect of Liraglutide on Bone Turnover, Bone Mass and Bone Cell Function (LIRABONE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02473809|
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : September 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Complications Osteoporosis||Drug: Liraglutide Drug: Placebo||Phase 4|
Background: Type 2 diabetes may cause complications such as ischemic heart disease, nephropathy, neuropathy, and retinopathy. Several epidemiologic and animal studies also suggest that fracture risk is increased in diabetes.
Bone is remodelled throughout life through bone resorption by the bone resorbing cells, the osteoclasts, and by bone formation by the bone forming cells, the osteoblasts. Bone remodelling can be monitored by biochemical markers of bone turnover and the effect of bone remodelling can be measured by changes in bone mineral density (BMD) by Dual X-ray absorptiometry (DXA) or bone structure by quantitative CT (QCT) or high resolution peripheral QCT (HRpQCT). The remodelling activity and the balance between resorption and formation are influenced by many factors including food consumption. The gut hormone glucagon-like polypeptide 1 (GLP-1) is released in relation to food intake and reduces serum levels of glucagon, increases serum levels of insulin, and reduces blood glucose in diabetes. Liraglutide is a GLP-1 analogue and has been approved for the treatment of type 2 diabetes.
Aim: To investigate the effect of the GLP-1 analogue Liraglutide on bone turnover, bone mass, and bone structure in patients with type 2 diabetes.
Methods: The clinical study will be conducted as a randomised, double-blinded, placebo-controlled, prospective, clinical trial with comparative treatment regimes with either subcutaneous Liraglutide or subcutaneous placebo injections.
Perspectives: The project will bring new knowledge about the possible effects of GLP-1 analogues on bone turnover and structure. This is important given that type 2 diabetes deteriorates bone health and increases risk of fractures. If Liraglutide can be demonstrated to have a positive effect on bone, this may be one among other factors to consider before the decision about specific treatment of type 2 diabetes is made for the individual patient.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Liraglutide on Bone Turnover, Bone Mass and Bone Cell Function|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
Liraglutide ("Victoza"), subcutaneous 1,8 mg once daily for 180 days
Other Name: Victoza
Placebo Comparator: Placebo
Saline, subcutaneous once daily for 180 days
Other Name: Saline
- Change in collagen I cross-linked C-terminal telopeptide measured in serum [ Time Frame: Days 0, 7, 28, 90, 180 ]Collagen I cross-linked C-terminal telopeptide has been chosen as primary endpoint as the expected mechanism of action is reduction in bone resorption, and as it is the most responsive bone resorption marker.
- Change in bone alkaline phosphatase measured in serum [ Time Frame: Days 0, 7, 28, 90, 180 ]
- Change in BMD evaluated by DXA [ Time Frame: Days 0, 90, 180 ]
- Change in bone structure evaluated by QCT and HRpQCT [ Time Frame: Days 0, 90, 180 ]
- Change in HbA1c [ Time Frame: Days 0, 180 ]
- Change in osteocalcin measured in serum [ Time Frame: Days 0, 7, 28, 90, 180 ]
- Change in procollagen type I N-terminal propeptide measured in serum [ Time Frame: Days 0, 7, 28, 90, 180 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473809
|Department of Endocrinology and Internal Medicine, Aarhus University Hospital|
|Aarhus, Aarhus C, Denmark, 8000|
|Study Director:||Bente L Langdahl, MD PhD DMSc||Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark|