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

Morten Frost

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Osteopenia

Treatments: Drug: Ozempic; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04702516

0052699 (Other Grant/Funding Number)

S-20200048

2020-000616-29 (EudraCT Number)

18/51856 (Other Grant/Funding Number)

A35844 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Semaglutide

Experimental group

Description:

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

Treatment:

Drug: Ozempic

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo