Status:
UNKNOWN
The Effect of Semaglutide on Bone Turnover in Patients With Increased Risk of Bone Fracture
Lead Sponsor:
Morten Frost
Collaborating Sponsors:
Esbjerg Hospital - University Hospital of Southern Denmark
Conditions:
Osteopenia
Eligibility:
All Genders
40-85 years
Phase:
PHASE1
PHASE2
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 yea...
Eligibility Criteria
Inclusion
- T-score \<-1 in hip or lower back, assessed by DXA scan and / or
- Low-energy fracture within the last 3 years
Exclusion
- 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
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04702516
Start Date
March 24 2021
End Date
August 31 2022
Last Update
March 30 2021
Active Locations (1)
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1
Odense University Hospital
Odense, Region Syddanmark, Denmark, 5000