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

Osteopenia Clinical Trial

Official title:

The Effect of Semaglutide (Ozempic) on Bone Turnover in Patients With Increased Fracture Risk: a Randomized Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04702516
• Other study ID #: S-20200048
• Secondary ID: 2020-000616-2900
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 24, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2021
• Source: Odense University Hospital
• Contact: Morten Steen Svarer Hansen, MD
• Phone: +4521249531
• Email: morten.steen.hansen[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia

Intervention

Drug:
• Ozempic
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.
• Placebo
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.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Region Of Southern Denmark

Sponsors (2)

Lead Sponsor	Collaborator
Morten Frost	Hospital of South West Jutland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mirco RNAs	Changes in expression of blood-circulating microRNAs (miRNAs) known to be involved in regulation of bone formation and bone resorption using qPCR	Baseline and 52 weeks
Primary	Procollagen type 1 N-terminal propeptide (P1NP)	Percentage changes in bone formation marker P1NP from baseline and after 12 months	Baseline and 52 weeks
Secondary	Collagen 1 cross link C-terminal telopeptide (CTX)	Changes in bone resorption marker CTX from baseline and after 12 months	Baseline and 52 weeks
Secondary	Tartrate-resistant acid phosphatase (TRAP)	Changes in bone resorption marker TRAP from baseline and after 12 months	Baseline and 52 weeks
Secondary	Osteocalcin	Changes in bone formation marker osteocalcin from baseline and after 12 months	Baseline and 52 weeks
Secondary	Bone specific alkaline phosphatase (BALP)	Changes in bone formation marker BALP from baseline and after 12 months	Baseline and 52 weeks
Secondary	BMSi	Changes in direct bone strength measured by microindentation from baseline and after 12 months	Baseline and 52 weeks
Secondary	Bone mineral density (BMD)	Changes in BMD (total hip, femoral neck and lumbar spine (L1-4)) assessed by DXA scans from baseline and after 12 months	Baseline and 52 weeks
Secondary	Estimated bone strength	Changes in estimated bone strength assessed by finite elemental analysis (HR-pQCT scan) from baseline and after 12 months	Baseline and 52 weeks
Secondary	Total volumetric BMD	Changes in total volumetric BMD (mg/cm^3) assessed by HR-pQCT scan of distal tibia and radius	Baseline and 52 weeks
Secondary	Trabecular volumetric BMD	Changes in trabecular volumetric BMD (mg/cm^3) assessed by HR-pQCT scan of distal tibia and radius	Baseline and 52 weeks
Secondary	Cortical volumetric BMD	Changes in cortical volumetric BMD (mg/cm^3) assessed by HR-pQCT scan of distal tibia and radius	Baseline and 52 weeks
Secondary	Bone volume	Changes in trabecular bone volume pr total volume (BV/TV) assessed by HR-pQCT scan of distal tibia and radius	Baseline and 52 weeks
Secondary	Trabecular thickness	Changes in trabecular thickness (mm) assessed by HR-pQCT scan of distal tibia and radius	Baseline and 52 weeks
Secondary	Cortical thickness	Changes in cortical thickness (mm) assessed by HR-pQCT scan of distal tibia and radius	Baseline and 52 weeks
Secondary	Cortical porosity	Changes in cortical porosity assessed by HR-pQCT scan of tibia and radius	Baseline and 52 weeks
Secondary	Bone formation rate	Changes in bone formation rate (BRF/BS, µm^3/µm^2 per day), the volume of mineralized bone made per unit surface of bone per year	52 weeks