The Effect of Semaglutide on Bone Turnover in Patients With Increased Risk of Bone Fracture

Morten Frost64 enrolled

Overview

The hypothesis for this study is that the GLP-1Ra Semaglutide has a positive effect on the balance between build-up and degradation as well as the strength of the bones in men and women aged 40-85 years at increased risk of bone fractures. Treatment involves injection of Semaglutide 1.34 mg/ml once a week or corresponding volume of placebo once a week for 52 weeks. The effect will be measured by bone markers in blood samples, bone scans, bone tissue tests (bone biopsy), and direct bone strength measured by microindentation at the start and end of the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osteopenia

Interventions

OzempicDRUG

2 mg prefilled pen for subcutaneous injection, 0.25 mg for two weeks then 0.5 mg for two weeks and then 1 mg for another 48 weeks.

PlaceboDRUG

2 mg prefilled pen for subcutaneous injection, 0.25 mg for two weeks then 0.5 mg for two weeks and then 1 mg for another 48 weeks.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * T-score \<-1 in hip or lower back, assessed by DXA scan and / or * Low-energy fracture within the last 3 years Exclusion Criteria: * T-score \<-2.5 in hip or lower back, assessed by DXA scan, although these individuals may be included if they prefer to participate or are not candidates for conventional therapy, e.g., by eGFR \<35 or adverse reaction (influenza-like symptoms, allergic reaction, etc.) to, e.g., bisphosphonate therapy * Diabetes type 1 and 2 * Heart failure similar to NYHA Class IV * Primary hyperparathyroidism * Vitamin D deficiency (\<25 nM) (re-test after substitution acceptable) * Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR \<20) or liver function (baseline phosphatase higher than twice upper limit (105 U/L)), rheumatism, celiac disease, hypogonadism, severe COPD, hypopituitarism, Cushing's disease * Antiresorptive or bone anabolic drugs for the last 12 months * Use of anabolic steroids in the previous year * History of pancreatitis * Allergy to the medicines used * Inability to give informed consent * BMI \<20 kg / m2

Locations (1)

Odense University Hospital

Odense, Region Syddanmark, Denmark

RECRUITING