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

NCT ID: NCT04702516

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-24
• Study Completion Date: 2022-08-31

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.

Conditions

Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Semaglutide

Ozempic 1 mg (or highest tolerated dose) s.c. once weekly for 52 weeks (incl. titration)

Group Type: EXPERIMENTAL

Ozempic

Intervention Type: DRUG

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

Placebo (saline) 1 mg (or highest tolerated dose) s.c. once weekly for 52 weeks (incl. titration)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role: collaborator

Morten Frost

OTHER

Sponsor Role: lead

Responsible Party

Morten Frost

Associate professor, clinical staff specialist, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Morten Frost, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

Odense University Hospital

Odense, Region Syddanmark, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Morten Steen Svarer Hansen, MD

Role: CONTACT

morten.steen.hansen@rsyd.dk

+4521249531

Morten Frost, MD

Role: CONTACT

mmfnielsen@health.sdu.dk

Facility Contacts

Morten Steen Hansen, MD

Role: primary

morten.steen.hansen@rsyd.dk

+4521249531

Morten Frost, MD

Role: backup

mmfnielsen@health.sdu.dk

+4522877448

References

Hansen MS, Wolfel EM, Jeromdesella S, Moller JK, Ejersted C, Jorgensen NR, Eastell R, Hansen SG, Frost M. Once-weekly semaglutide versus placebo in adults with increased fracture risk: a randomised, double-blinded, two-centre, phase 2 trial. EClinicalMedicine. 2024 May 3;72:102624. doi: 10.1016/j.eclinm.2024.102624. eCollection 2024 Jun.

Reference Type: DERIVED

PMID: 38737002 (View on PubMed)

Other Identifiers

2020-000616-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0052699

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

18/51856

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

A35844

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S-20200048

Identifier Type: -

Identifier Source: org_study_id