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

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide for osteoporosis and bone density.

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.

It had two arms (groups): Liraglutide (experimental) and Placebo (placebo comparator).

Saline, subcutaneous once daily for 180 days.

The registry classes the interventions as drug.

More on the Plan

Background: Type 2 diabetes may cause complications such as ischemic heart disease, nephropathy, neuropathy, and retinopathy.

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.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to people of any sex aged from 30 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age older than 30 years.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: type 1 diabetes; treatment with insulin; body weight \> 140 kg.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Liraglutide group and the comparison group ran side by side rather than switching.

Neither the osteoporosis and bone density participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-08 with completion listed for 2017-10.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in collagen I cross-linked C-terminal telopeptide measured in serum (time frame: Days 0, 7, 28, 90, 180).

It also tracked 6 secondary outcomes, for example Change in bone alkaline phosphatase measured in serum, Change in BMD evaluated by DXA, Change in bone structure evaluated by QCT and HRpQCT, Change in HbA1c, Change in osteocalcin measured in serum and Change in procollagen type I N-terminal propeptide measured in serum.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 60 people with osteoporosis and bone density.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, Osteoporosis and bone density research.