OsteopeniaPhase 1/2NCT04702516
The Effect of Semaglutide on Bone Turnover in Patients With Increased Risk of Bone Fracture
A Phase 1/2 study testing Ozempic in people with Osteopenia, run by Morten Frost at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteopenia
- What is being tested?
- Ozempic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Mar 2021to 31 Aug 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- T-score <-1 in hip or lower back, assessed by DXA scan and / or
- Low-energy fracture within the last 3 years
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Morten Frost, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, Region Syddanmark, 5000
Morten Steen Hansen, MD, +4521249531, morten.steen.hansen@rsyd.dk
Morten Frost, MD, +4522877448, mmfnielsen@health.sdu.dk
About this study
Official title: The Effect of Semaglutide (Ozempic) on Bone Turnover in Patients With Increased Fracture Risk: a Randomized Placebo-controlled Clinical Trial
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.
- Conditions
- Osteopenia
- Being tested
- Ozempic, Placebo
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzempicDrug
2 mg prefilled pen for subcutaneous injection, 0.25 mg for two weeks then 0.5 mg for two weeks and then 1 mg for another 48 weeks.
PlaceboDrug
2 mg prefilled pen for subcutaneous injection, 0.25 mg for two weeks then 0.5 mg for two weeks and then 1 mg for another 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Ozempic 1 mg (or highest tolerated dose) s.c. once weekly for 52 weeks (incl. titration) Receives: Drug: Ozempic |
| Placebo | Placebo comparator | Placebo (saline) 1 mg (or highest tolerated dose) s.c. once weekly for 52 weeks (incl. titration) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procollagen type 1 N-terminal propeptide (P1NP)
Percentage changes in bone formation marker P1NP from baseline and after 12 months
Measured: Baseline and 52 weeks
Secondary outcomes (15)
Collagen 1 cross link C-terminal telopeptide (CTX)
Changes in bone resorption marker CTX from baseline and after 12 months
Measured: Baseline and 52 weeks
Tartrate-resistant acid phosphatase (TRAP)
Changes in bone resorption marker TRAP from baseline and after 12 months
Measured: Baseline and 52 weeks
Osteocalcin
Changes in bone formation marker osteocalcin from baseline and after 12 months
Measured: Baseline and 52 weeks
Bone specific alkaline phosphatase (BALP)
Changes in bone formation marker BALP from baseline and after 12 months
Measured: Baseline and 52 weeks
BMSi
Changes in direct bone strength measured by microindentation from baseline and after 12 months
Measured: Baseline and 52 weeks
Bone mineral density (BMD)
Changes in BMD (total hip, femoral neck and lumbar spine (L1-4)) assessed by DXA scans from baseline and after 12 months
Measured: Baseline and 52 weeks
Estimated bone strength
Changes in estimated bone strength assessed by finite elemental analysis (HR-pQCT scan) from baseline and after 12 months
Measured: Baseline and 52 weeks
Total volumetric BMD
Changes in total volumetric BMD (mg/cm^3) assessed by HR-pQCT scan of distal tibia and radius
Measured: Baseline and 52 weeks
Trabecular volumetric BMD
Changes in trabecular volumetric BMD (mg/cm^3) assessed by HR-pQCT scan of distal tibia and radius
Measured: Baseline and 52 weeks
Cortical volumetric BMD
Changes in cortical volumetric BMD (mg/cm^3) assessed by HR-pQCT scan of distal tibia and radius
Measured: Baseline and 52 weeks
Bone volume
Changes in trabecular bone volume pr total volume (BV/TV) assessed by HR-pQCT scan of distal tibia and radius
Measured: Baseline and 52 weeks
Trabecular thickness
Changes in trabecular thickness (mm) assessed by HR-pQCT scan of distal tibia and radius
Measured: Baseline and 52 weeks
Cortical thickness
Changes in cortical thickness (mm) assessed by HR-pQCT scan of distal tibia and radius
Measured: Baseline and 52 weeks
Cortical porosity
Changes in cortical porosity assessed by HR-pQCT scan of tibia and radius
Measured: Baseline and 52 weeks
Bone formation rate
Changes in bone formation rate (BRF/BS, µm^3/µm^2 per day), the volume of mineralized bone made per unit surface of bone per year
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start24 Mar 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morten Frost
- Sponsor type
- University, hospital or other
- Collaborators
- Esbjerg Hospital - University Hospital of Southern Denmark
- Responsible party
- Sponsor-investigator, Morten Frost, Odense University Hospital
- Investigators
- Morten Frost, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702516
- Sponsor's protocol ID
- S-20200048
- Other IDs
- 2020-000616-29, 0052699, 18/51856, A35844
- Status last verified
- Mar 2021
- First submitted
- 9 Dec 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hansen MS, Wolfel EM, Jeromdesella S, Moller JK, Ejersted C, Jorgensen NR, Eastell R, Hansen SG, Frost M. Once-weekly semaglutide versus placebo in adults with increased fracture risk: a randomised, double-blinded, two-centre, phase 2 trial. EClinicalMedicine. 2024 May 3;72:102624. doi: 10.1016/j.eclinm.2024.102624. eCollection 2024 Jun.
PubMed 38737002
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Semaglutide (Ozempic) on Bone Turnover in Patients With Increased Fracture Risk: a Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04702516
- Acronym / sponsor ID
- S-20200048
- Conditions
- Osteopenia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Morten FrostUniversity, hospital or other
- Collaborators
- Esbjerg Hospital - University Hospital of Southern Denmark
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: OzempicOzempic 1 mg (or highest tolerated dose) s.c. once weekly for 52 weeks (incl. titration) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (saline) 1 mg (or highest tolerated dose) s.c. once weekly for 52 weeks (incl. titration) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- T-score <-1 in hip or lower back, assessed by DXA scan and / or
- Low-energy fracture within the last 3 years
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozempic2 mg prefilled pen for subcutaneous injection, 0.25 mg for two weeks then 0.5 mg for two weeks and then 1 mg for another 48 weeks. | Drug | Semaglutide |
| Placebo2 mg prefilled pen for subcutaneous injection, 0.25 mg for two weeks then 0.5 mg for two weeks and then 1 mg for another 48 weeks. | Drug | Placebo |
Primary outcome
Procollagen type 1 N-terminal propeptide (P1NP)
Time frame: Baseline and 52 weeks
Percentage changes in bone formation marker P1NP from baseline and after 12 months
15 secondary outcomes
Collagen 1 cross link C-terminal telopeptide (CTX)
Time frame: Baseline and 52 weeks
Tartrate-resistant acid phosphatase (TRAP)
Time frame: Baseline and 52 weeks
Osteocalcin
Time frame: Baseline and 52 weeks
Bone specific alkaline phosphatase (BALP)
Time frame: Baseline and 52 weeks
BMSi
Time frame: Baseline and 52 weeks
Bone mineral density (BMD)
Time frame: Baseline and 52 weeks
Estimated bone strength
Time frame: Baseline and 52 weeks
Total volumetric BMD
Time frame: Baseline and 52 weeks
Trabecular volumetric BMD
Time frame: Baseline and 52 weeks
Cortical volumetric BMD
Time frame: Baseline and 52 weeks
Bone volume
Time frame: Baseline and 52 weeks
Trabecular thickness
Time frame: Baseline and 52 weeks
Cortical thickness
Time frame: Baseline and 52 weeks
Cortical porosity
Time frame: Baseline and 52 weeks
Bone formation rate
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 38737002Hansen MS, Wolfel EM, Jeromdesella S, Moller JK, Ejersted C, Jorgensen NR, Eastell R, Hansen SG, Frost M. Once-weekly semaglutide versus placebo in adults with increased fracture risk: a randomised, double-blinded, two-centre, phase 2 trial. EClinicalMedicine. 2024 May 3;72:102624. doi: 10.1016/j.eclinm.2024.102624. eCollection 2024 Jun.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Frost, MD contact
Morten Frost, MD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ozempic in people with Osteopenia, run by Morten Frost at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morten Steen Svarer Hansen, MD (+4521249531, morten.steen.hansen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procollagen type 1 N-terminal propeptide (P1NP) (time frame: Baseline and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04702516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.