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UnknownPhase 1, PHASE2

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

The Effect of Semaglutide (Ozempic) on Bone Turnover in Patients With Increased Fracture Risk: a Randomized Placebo-controlled Clinical Trial

Lead sponsor

Morten Frost

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Estimated enrollment

64

Study population

Osteoporosis / bone

Eligibility highlights

-

Primary endpoint

•Procollagen type 1 N-terminal propeptide (P1NP)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04702516
Org study IDS-20200048
Secondary ID0052699Novo Nordisk Foundation
Secondary ID18/51856Region of Southern Denmark
Secondary ID2020-000616-29
Secondary IDA35844Gangsted Foundation

Timeline

Milestones

Study first posted2021-01-11actual
Study start2021-03-24actual
Last update posted2021-03-30actual
Primary completion2022-08-31estimated
Study completion2022-08-31estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Osteoporosis / bone

Who can enroll

Minimum age40 Years
Maximum age85 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
13
Other (unclassified)
3
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Cortical volumetric BMD

Time frame:Baseline and 52 weeks

change from baseline, improvement

Other clinical outcomes

13 endpoints
Secondary/protocol endpoint

Collagen 1 cross link C-terminal telopeptide (CTX)

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Osteocalcin

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Bone specific alkaline phosphatase (BALP)

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

BMSi

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Bone mineral density (BMD)

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Estimated bone strength

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Total volumetric BMD

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Trabecular volumetric BMD

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Bone volume

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Trabecular thickness

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Cortical thickness

Time frame:Baseline and 52 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Cortical porosity

Time frame:Baseline and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Bone formation rate

Time frame:52 weeks

change from baseline, improvement

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Procollagen type 1 N-terminal propeptide (P1NP)

Time frame:Baseline and 52 weeks

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Tartrate-resistant acid phosphatase (TRAP)

Time frame:Baseline and 52 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Mirco RNAs

Time frame:Baseline and 52 weeks

change from baseline, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.