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The Effect of Liraglutide on Bone Turnover, Bone Mass and Bone Cell Function (LIRABONE)

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ClinicalTrials.gov Identifier: NCT02473809
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : September 26, 2018
Sponsor:
Collaborators:
Aarhus University Hospital
Novo Nordisk A/S
Information provided by (Responsible Party):
University of Aarhus

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Complications Osteoporosis Drug: Liraglutide Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density
Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide
Liraglutide ("Victoza"), subcutaneous 1,8 mg once daily for 180 days
Drug: Liraglutide
Once daily
Other Name: Victoza

Placebo Comparator: Placebo
Saline, subcutaneous once daily for 180 days
Drug: Placebo
Once daily
Other Name: Saline




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in bone alkaline phosphatase measured in serum [ Time Frame: Days 0, 7, 28, 90, 180 ]
  2. Change in BMD evaluated by DXA [ Time Frame: Days 0, 90, 180 ]
  3. Change in bone structure evaluated by QCT and HRpQCT [ Time Frame: Days 0, 90, 180 ]
  4. Change in HbA1c [ Time Frame: Days 0, 180 ]
  5. Change in osteocalcin measured in serum [ Time Frame: Days 0, 7, 28, 90, 180 ]
  6. Change in procollagen type I N-terminal propeptide measured in serum [ Time Frame: Days 0, 7, 28, 90, 180 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Diagnosis of type 2 diabetes (HbA1c > 48 mmol/mol)
  • Age older than 30 years

Exclusion Criteria:

  • Type 1 diabetes
  • Treatment with insulin
  • Body weight > 140 kg
  • HbA1c > 75 mmol/mol
  • Treatment with GLP-1 analogues, Dipeptidyl peptidase-4 inhibitors, or glitazones
  • Chronic kidney disease
  • Hepatic disease
  • Pancreatitis
  • Inflammatory bowel disease
  • Osteoporosis
  • Family or personal history of medullary thyroid carcinoma
  • Treatment with glucocorticoids
  • Hormone replacement therapy
  • Diabetic gastroparesis
  • Pregnancy or lactation

Information from the National Library of Medicine

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


Locations
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Denmark
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Novo Nordisk A/S
Investigators
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Study Director: Bente L Langdahl, MD PhD DMSc Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark
Publications:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02473809    
Other Study ID Numbers: 07052015
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Osteoporosis
Diabetes Complications
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists