The Effect of Liraglutide on Bone Turnover, Bone Mass and Bone Cell Function
Condition: Diabetes Complications; Osteoporosis
MeSH terms: Osteoporosis; Diabetes Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test whether liraglutide, a drug approved and widely used in
      the treatment of type 2 diabetes, has an effect on bone mass and bone cell function. Type 2
      diabetes may cause multiple complications, and it is well known that patients with type 2
      diabetes have a higher 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.
    

Detailed description: 
      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.
    

Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once daily; Once daily
Other intervention name(s): Victoza; Saline
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment