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

  • days left to enroll
  • participants needed
  • sponsor
    Morten Frost
Updated on 7 April 2021


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.

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


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
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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.

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