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Trial · Interventional

CompletedPhase 4Registry data

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

Short name LIRABONE

NCTNCT02473809 (opens ClinicalTrials.gov in a new tab)Other id07052015
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
60 participants (actual)
Sponsor
University of Aarhus · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
Aug 2015
Primary completion
Oct 2017
Completion
Oct 2017
First posted
17 Jun 2015 (estimated)
Last update posted
26 Sept 2018
Conditions
Diabetes Complications · Osteoporosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 4

    LIRABONE

    NCT02473809

    Aug 2015 to Oct 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Liraglutide

    Liraglutide ("Victoza"), subcutaneous 1,8 mg once daily for 180 days

  • Placebo comparator

    Placebo

    Saline, subcutaneous once daily for 180 days

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in collagen I cross-linked C-terminal telopeptide measured in serum

    Time frame · Days 0, 7, 28, 90, 180

    Registry description

    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 outcomes(6)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Meta-analysis (pooled) · 2015

1 result

Risk of bone fractures associated with glucagon-like peptide-1 receptor agonists' treatment: a meta-analysis of randomized controlled trials.

Su et al. 2015Endocrinecited by 158

PMID 25074632DOI 10.1007/s12020-014-0361-4PUB-25074632

Full text at the publisher1 result
Publisher pageSee results (1)

PubMed tag: none · 2011

10 results

GLP-1 and exendin-4 can reverse hyperlipidic-related osteopenia.

Nuche-Berenguer et al. 2011The Journal of endocrinologycited by 79

PMID 21372151DOI 10.1530/joe-11-0015PUB-21372151

Full text at the publisher10 results
Publisher pageSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 90 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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