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

  • STATUS
    Recruiting
  • days left to enroll
    66
  • participants needed
    64
  • sponsor
    Morten Frost
Updated on 7 April 2021

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.

Details
Condition Metabolic disorder, Metabolic Disorders, Osteopenia, Osteopenia, Bone Diseases, Bone Diseases, Metabolic Disorders, bone loss, low bone density, decreased bone mineral density
Treatment Placebo, Ozempic
Clinical Study IdentifierNCT04702516
SponsorMorten Frost
Last Modified on7 April 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note