Clinical trial NCT04702516: The Effect of Semaglutide on Bone Turnover in Patients With Increased Risk of Bone Fracture
Official title: The Effect of Semaglutide (Ozempic) on Bone Turnover in Patients With Increased Fracture Risk: a Randomized Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Osteopenia
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Esbjerg Hospital - University Hospital of Southern Denmark
First posted: 2021-01-11
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Procollagen type 1 N-terminal propeptide (P1NP)
timeFrame: Baseline and 52 weeks
Secondary outcomes:
measure: Collagen 1 cross link C-terminal telopeptide (CTX)
timeFrame: Baseline and 52 weeks
measure: Tartrate-resistant acid phosphatase (TRAP)
timeFrame: Baseline and 52 weeks
measure: Osteocalcin
timeFrame: Baseline and 52 weeks
measure: Bone specific alkaline phosphatase (BALP)
timeFrame: Baseline and 52 weeks
measure: BMSi
timeFrame: Baseline and 52 weeks
measure: Bone mineral density (BMD)
timeFrame: Baseline and 52 weeks
measure: Estimated bone strength
timeFrame: Baseline and 52 weeks
measure: Total volumetric BMD
timeFrame: Baseline and 52 weeks
measure: Trabecular volumetric BMD
timeFrame: Baseline and 52 weeks
measure: Cortical volumetric BMD
timeFrame: Baseline and 52 weeks
measure: Bone volume
timeFrame: Baseline and 52 weeks
measure: Trabecular thickness
timeFrame: Baseline and 52 weeks
measure: Cortical thickness
timeFrame: Baseline and 52 weeks
measure: Cortical porosity
timeFrame: Baseline and 52 weeks
measure: Bone formation rate
timeFrame: 52 weeks
Other outcomes:
measure: Mirco RNAs
timeFrame: Baseline and 52 weeks
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region Of Southern Denmark
Study officials:
affiliation: Odense University Hospital
name: Morten Frost, MD
role: PRINCIPAL_INVESTIGATOR
References: