Does an approved treatment for type 2 diabetes decrease the risk of fractures in patients with type 2 diabetes?

The effect of liraglutide on bone turnover, bone mass and bone cell function

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001284-40-DK

Enrollment

Registered

2015-03-24

Start date

2015-05-20

Completion date

Unknown

Last updated

2018-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus MedDRA version: 19.0 Level: LLT Classification code 10029505 Term: Non-insulin-dependent diabetes mellitus System Organ Class: 100000004861

Interventions

Trade Name: Victoza Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Current Sponsor code: 160315 Other descriptive name: liraglut

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Informed consent Diagnosis of type 2 diabetes (HbA1c higher than 48 mmol/mol) Postmenopausal (2 years since last menstrual bleeding) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Type 1 diabetes Treatment with insulin Body weight higher than 140 kg Treatment with GLP-1 analogues, DPP-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

Design outcomes

Primary

Measure	Time frame
Main Objective: The aims of the study are to investigate the effect of the GLP-1 analogue liraglutide ("Victoza") in postmenopausal women with type 2 diabetes on bone turnover, bone mass, and bone structure.;Secondary Objective: not applicable;Primary end point(s): Reduction in the bone resorption marker collagen I cross-linked C-terminal telopeptide measured in serum.;Timepoint(s) of evaluation of this end point: Days 0, 7, 28, 90 and 180	—

Measure

Time frame

Main Objective: The aims of the study are to investigate the effect of the GLP-1 analogue liraglutide ("Victoza") in postmenopausal women with type 2 diabetes on bone turnover, bone mass, and bone structure.;Secondary Objective: not applicable;Primary end point(s): Reduction in the bone resorption marker collagen I cross-linked C-terminal telopeptide measured in serum.;Timepoint(s) of evaluation of this end point: Days 0, 7, 28, 90 and 180

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Secondary

Measure	Time frame
Secondary end point(s): Change in the bone formation markers bone alkaline phosphatase, osteocalcin, and procollagen type I N-terminal propeptide. Change in BMD. Change in bone structure evaluated by QCT and HRpQCT. Change in HbA1c.;Timepoint(s) of evaluation of this end point: Alkaline phosphatase, osteocalcin, and procollagen type I N-terminal propeptide, and HbA1c: days 0, 7, 28, 90 and 180. BMD and change in bone structure: days 0, 90 and 180.	—

Measure

Time frame

Secondary end point(s): Change in the bone formation markers bone alkaline phosphatase, osteocalcin, and procollagen type I N-terminal propeptide. Change in BMD. Change in bone structure evaluated by QCT and HRpQCT. Change in HbA1c.;Timepoint(s) of evaluation of this end point: Alkaline phosphatase, osteocalcin, and procollagen type I N-terminal propeptide, and HbA1c: days 0, 7, 28, 90 and 180. BMD and change in bone structure: days 0, 90 and 180.

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Countries

Denmark

Contacts

Public ContactDepartment of Endocrinology

Aarhus University Hospital

katrhygu@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026