NCT04702516

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 24, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

December 9, 2020

Last Update Submit

March 26, 2021

Conditions

Osteopenia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • Collagen 1 cross link C-terminal telopeptide (CTX)

    Baseline and 52 weeks

  • Tartrate-resistant acid phosphatase (TRAP)

    Baseline and 52 weeks

  • Osteocalcin

    Baseline and 52 weeks

  • Bone specific alkaline phosphatase (BALP)

    Baseline and 52 weeks

  • BMSi

    Baseline and 52 weeks

  • +10 more secondary outcomes

Other Outcomes (1)

  • Mirco RNAs

    Baseline and 52 weeks

Study Arms (2)

Semaglutide

EXPERIMENTAL

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

Drug: Ozempic

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

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.

Semaglutide
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.

Placebo

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • T-score \<-1 in hip or lower back, assessed by DXA scan and / or
  • Low-energy fracture within the last 3 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38737002DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Morten Frost, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Morten Steen Svarer Hansen, MD

CONTACT

+4521249531morten.steen.hansen@rsyd.dk

Morten Frost, MD

CONTACT

mmfnielsen@health.sdu.dk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor, clinical staff specialist, PhD

Study Record Dates

First Submitted

December 9, 2020

First Posted

January 11, 2021

Study Start

March 24, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations

DK(1)