Osteogenesis ImperfectaPhase 3NCT05972551
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
A Phase 3 study testing Romosozumab and Bisphosphonate in people with Osteogenesis Imperfecta, run by Amgen at 65 sites in 18 countries.
Trial summary
The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- Romosozumab and Bisphosphonate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 65 sitesin 18 countries
- Study dates
- 22 Apr 2024to 30 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
- OR
- Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
- Ambulatory male and female children and adolescents, age 5 to <18 years, including ambulatory with assistance as defined in the pediatric osteogenesis imperfecta (OI) population.
- Clinical diagnosis of OI, defined as clinical history consistent with type I, III, or IV OI as determined by presence of expected phenotype (examples include: facial shape, voice, blue sclera, dentinogenesis imperfecta, typical radiographic features, fracture pattern) and lack of additional features unrelated to type I, III, or IV OI (eg, blindness, mental retardation, neuropathy, and craniosynostosis).
- o If familial, also must be autosomal dominant.
Show all 10Show fewer
- Meets at least one of the following:
- 3 or more fractures within the previous 2 years, or
- 1 or more nonvertebral fracture(s) within the previous 2 years and at least 1 prevalent vertebral fracture, or
- 2 or more prevalent vertebral fractures.
Who cannot join
- Disease Related
- History of an electrophoresis pattern inconsistent with type I, III or IV OI.
- History of known mutation in a gene other than collagen type I alpha 1/collagen type I alpha 2 (COL1A1/COL1A2) causing OI or other metabolic bone disease.
- History of congenital dislocation of the radial head, interosseous membrane calcification, or exuberant callus formation.
Trial locations and contacts
65 sites in 18 countries.
65 sites in 18 countries
United States14 sites
Emory University
Atlanta, Georgia, 30322
Kennedy Krieger Institute
Baltimore, Maryland, 21287
Childrens Hospital of Alabama
Birmingham, Alabama, 35233
Boston Childrens Hospital
Boston, Massachusetts, 02115
Indiana University
Indianapolis, Indiana, 46202
University of California, Los Angeles Interventional Clinical Trials
Los Angeles, California, 90095
Marshfield Clinic
Marshfield, Wisconsin, 54449
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-3157
Nemours Childrens Hospital
Orlando, Florida, 32827
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Mayo Clinic Childrens Center
Rochester, Minnesota, 55905
Gillette Childrens Hospital and Clinic Saint Paul
Saint Paul, Minnesota, 55101
University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
Tampa, Florida, 33606
Nemours Hospital for Children
Wilmington, Delaware, 19803
China8 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
West China Hospital Sichuan University
Chengdu, Sichuan, 610044
Shandong Provincial Hospital
Jinan, Shandong, 250021
Shanghai Sixth Peoples Hospital
Shanghai, 200233
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518053
Childrens Hospital of Soochow University
Suzhou, Jiangsu, 215000
Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Japan6 sites
Tokyo Metropolitan Children's Medical Center
Fuchu-shi, Tokyo, 183-8561
Osaka Womens and Childrens Hospital
Izumi-shi, Osaka, 594-1101
Okayama Saiseikai Outpatient Center Hospital
Okayama, Okayama-ken, 700-0013
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
National Center for Child Health and Development
Setagaya-ku, Tokyo, 157-8535
Tottori University Hospital
Yonago-shi, Tottori, 683-8504
Spain6 sites
Hospital de Cruces
Barakaldo, Basque Country, 48903
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, 08950
Hospital Universitario de Getafe
Getafe, Madrid, 28905
Hospital Universitario Infantil Niño Jesus
Madrid, 28009
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
Poland5 sites
Centermed Krakow Sp zoo
Krakow, 31-530
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny UMeds
Lodz, 91-738
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338
Centrum Medyczne Medyk Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa
Rzeszów, 35-326
Szpital Miejski w Tychach Spolka z ograniczona odpowiedzialnoscia
Tychy, 43-100
Turkey (Türkiye)4 sites
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, 06500
Marmara Universitesi Tip Fakultesi Hastanesi
Istanbul, 34890
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100
Karadeniz Teknik Universitesi Tip Fakultesi
Trabzon, 61080
Canada3 sites
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec, H3T 1C5
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
France3 sites
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux, 33076
Centre Hospitalier Regional Universitaire de Lille
Lille, 59037
Hopital Necker Enfants Malades
Paris, 75743
United Kingdom3 sites
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Royal Manchester Childrens Hospital
Manchester, M13 9WL
Sheffield Childrens Hospital
Sheffield, S10 2TH
Australia2 sites
Monash Childrens Hospital
Clayton, Victoria, 3168
Perth Childrens Hospital
Nedlands, Western Australia, 6909
Germany2 sites
Universitaetsklinikum Koeln
Cologne, 50937
Universitaetsklinikum Wuerzburg
Würzburg, 97074
Italy2 sites
IRCCS Istituto Giannina Gaslini
Genova, 16147
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, 37134
Switzerland2 sites
Universitaets-Kinderspital beider Basel
Basel, 4031
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Belgium1 site
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000
Saudi Arabia1 site
King Faisal Specialist Hospital and Research Centre
Riyadh, 11564
About this study
Official title: A Phase 3, Open-Label, Multicenter, Randomized Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- Romosozumab, Bisphosphonate
- Keywords
- Osteogenesis Imperfecta, Romosozumab, EVENITY®, Bisphosphonates
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomosozumabDrug
Also called EVENITY®
Subcutaneous (SC) injection
BisphosphonateDrug
Administration determined by investigator according to the local standard of care
| Study group | Role | What they receive |
|---|---|---|
| Romosozumab | Experimental | Participants will receive romosozumab once a month (QM) for 12 months. Receives: Drug: Romosozumab |
| Standard of Care Bisphosphonate | Active comparator | Participants will receive bisphosphonates per local standard of care treatment regimens, as determined by the investigator for 12 months. Receives: Drug: Bisphosphonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Clinical Fractures
Clinical fractures include clinical vertebral fractures and nonvertebral fractures.
Measured: 12 months
Number of Any Fractures
Fractures include new and worsening vertebral compression fractures, whether clinically silent or manifest, and nonvertebral fractures.
Measured: 12 months
Change from Baseline in Lumbar Spine BMD Z-score at 12 Months, as assessed by DXA
Measured: Baseline and 12 months
Secondary outcomes (21)
Change from Baseline in lumbar spine BMD Z-score at 6 months and 12 months, as assessed by DXA
Measured: Baseline, 6 months, and 12 months
Change from Baseline in Total Hip BMD Z-score at 6 Months and at 12 Months, as assessed by DXA
Measured: Baseline, 6 months, and 12 months
Change from Baseline in Femoral Neck BMD Z-score at 6 Months and at 12 Months, as assessed by DXA
Measured: Baseline, 6 months, and 12 months
Number of Participants with Any Fractures
Measured: 12 months
Number of Participants with Clinical Fractures
Measured: 12 months
Number of Participants with New or Worsening Vertebral Fractures
Measured: 12 months
Number of Participants with Nonvertebral Fractures
Measured: 12 months
Number of Participants with Long Bone Fractures
Measured: 12 months
Number of New or Worsening Vertebral Fractures
Measured: 12 months
Number of Nonvertebral Fractures
Measured: 12 months
Number of Long Bone Fractures
Measured: 12 months
Change from Baseline in Child Health Questionnaire - Parent Version (CHQ-PF-50) Physical Summary Score
The CHQ-PF-50 measures how a child's condition affects their ability to function in daily life. The CHQ-PF-50 measures 50 items in the following domains: physical functioning, role/social limitations - physical, general health perceptions, bodily pain/discomfort, family activities, role/social limitations - emotional/behavioral, parent impact - time, parent impact - emotion, self-esteem, mental health, behavior, family cohesion, change in health.
Each item is rated on a scale from "without any difficulty" to "unable to do". Total scores for each item are transformed to 0 - 100 scale, with lower scores indicating worse health states. Higher change from baseline scores indicate better or more positive health states.
Measured: Baseline and 12 months
Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Score
The CHAQ measures how a child's condition affects their ability to function in daily life. The CHAQ measures 50 items in the following domains: physical functioning, role/social limitations - physical, general health perceptions, bodily pain/discomfort, family activities, role/social limitations emotional/behavioral, self-esteem, mental health, behavior, family cohesion, change in health.
Each item is rated on a scale from "without any difficulty" to "unable to do". Total scores for each item are transformed to 0 - 100 scale, with lower scores indicating worse health states. Higher change from baseline scores indicate better or more positive health states.
Measured: Baseline and 12 months
Change from Baseline in the Wong-Baker Faces Pain Rating Scale
The Wong-Baker Faces Pain Rating Scale is a horizontal pain scale that consists of six hand-drawn faces that range from a smiling "no hurt" face with a score of 0 to a crying "hurts worst" face with a score of 10. Greater change from baseline scores indicate greater pain experienced by the participant.
Measured: Baseline and 12 months
Serum Concentration of Romosozumab
Measured: Day 1 to Month 12
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs) at 12 Months
Any clinically signification change from baseline in laboratory values and vital signs after first dose will be recorded as a TEAE.
Measured: 12 months
Number of Participants who Experience TEAEs from Month 12 to Month 15
Any clinically signification change from baseline in laboratory values and vital signs after first dose will be recorded as a TEAE.
Measured: Month 12 to Month 15
Number of Participants with Anti-drug Antibodies (ADA) to Romosozumab
Measured: Up to 15 months
Number of Participants who Experience TEAEs at 15 Months
Any clinically signification change from baseline in laboratory values and vital signs after first dose will be recorded as a TEAE.
Measured: 15 months
Number of Participants with a Narrowing from Baseline to 6 Months in the Intracranial Nerve Tract in the Cranium and Vault of the Skull
Measured in a subset of participants who receive cranial nerve computerized tomography (CT) scans.
Measured: Baseline and 6 months
Number of Participants with a Narrowing from Baseline to 12 Months in the Intracranial Nerve Tract in the Cranium and Vault of the Skull
Measured in a subset of participants who receive cranial nerve CT scans.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start22 Apr 2024
- Primary completion4 May 2027 (estimated)
- Study completion30 Jul 2027 (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 Osteogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972551
- Sponsor's protocol ID
- 20200105
- Other IDs
- 2023-503294-37, 2023
- Status last verified
- May 2026
- First submitted
- 24 Jul 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Publications
Bartosik M, Windels O, von Brackel FN, Amling M, Oheim R. Romosozumab in postmenopausal women with classical Osteogenesis imperfecta. Arch Osteoporos. 2026 Jul 18;21(1):100. doi: 10.1007/s11657-026-01744-3.
PubMed 42470570
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label, Multicenter, Randomized Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
- ClinicalTrials.gov ID
- NCT05972551
- Acronym / sponsor ID
- 20200105
- Conditions
- Osteogenesis Imperfecta
- Keywords
- Osteogenesis Imperfecta, Romosozumab, EVENITY®, Bisphosphonates
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 111 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 4 May 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 2 Aug 2023 (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 primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romosozumab | Experimental | Drug: RomosozumabParticipants will receive romosozumab once a month (QM) for 12 months. |
| Standard of Care Bisphosphonate | Active comparator | Drug: BisphosphonateParticipants will receive bisphosphonates per local standard of care treatment regimens, as determined by the investigator for 12 months. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
- OR
- Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
- Ambulatory male and female children and adolescents, age 5 to <18 years, including ambulatory with assistance as defined in the pediatric osteogenesis imperfecta (OI) population.
- Clinical diagnosis of OI, defined as clinical history consistent with type I, III, or IV OI as determined by presence of expected phenotype (examples include: facial shape, voice, blue sclera, dentinogenesis imperfecta, typical radiographic features, fracture pattern) and lack of additional features unrelated to type I, III, or IV OI (eg, blindness, mental retardation, neuropathy, and craniosynostosis).
Key exclusion criteria (4 listed)
- Disease Related
- History of an electrophoresis pattern inconsistent with type I, III or IV OI.
- History of known mutation in a gene other than collagen type I alpha 1/collagen type I alpha 2 (COL1A1/COL1A2) causing OI or other metabolic bone disease.
- History of congenital dislocation of the radial head, interosseous membrane calcification, or exuberant callus formation.
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 |
|---|---|---|
| RomosozumabAlso: EVENITY®Subcutaneous (SC) injection | Drug | Romosozumab |
| BisphosphonateAdministration determined by investigator according to the local standard of care | Drug | Standard of Care Bisphosphonate |
Primary outcome
Number of Clinical Fractures
Time frame: 12 months
Clinical fractures include clinical vertebral fractures and nonvertebral fractures.
Number of Any Fractures
Time frame: 12 months
Fractures include new and worsening vertebral compression fractures, whether clinically silent or manifest, and nonvertebral fractures.
Change from Baseline in Lumbar Spine BMD Z-score at 12 Months, as assessed by DXA
Time frame: Baseline and 12 months
21 secondary outcomes
Change from Baseline in lumbar spine BMD Z-score at 6 months and 12 months, as assessed by DXA
Time frame: Baseline, 6 months, and 12 months
Change from Baseline in Total Hip BMD Z-score at 6 Months and at 12 Months, as assessed by DXA
Time frame: Baseline, 6 months, and 12 months
Change from Baseline in Femoral Neck BMD Z-score at 6 Months and at 12 Months, as assessed by DXA
Time frame: Baseline, 6 months, and 12 months
Number of Participants with Any Fractures
Time frame: 12 months
Number of Participants with Clinical Fractures
Time frame: 12 months
Number of Participants with New or Worsening Vertebral Fractures
Time frame: 12 months
Number of Participants with Nonvertebral Fractures
Time frame: 12 months
Number of Participants with Long Bone Fractures
Time frame: 12 months
Number of New or Worsening Vertebral Fractures
Time frame: 12 months
Number of Nonvertebral Fractures
Time frame: 12 months
Number of Long Bone Fractures
Time frame: 12 months
Change from Baseline in Child Health Questionnaire - Parent Version (CHQ-PF-50) Physical Summary Score
Time frame: Baseline and 12 months
Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Score
Time frame: Baseline and 12 months
Change from Baseline in the Wong-Baker Faces Pain Rating Scale
Time frame: Baseline and 12 months
Serum Concentration of Romosozumab
Time frame: Day 1 to Month 12
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs) at 12 Months
Time frame: 12 months
Number of Participants who Experience TEAEs from Month 12 to Month 15
Time frame: Month 12 to Month 15
Number of Participants with Anti-drug Antibodies (ADA) to Romosozumab
Time frame: Up to 15 months
Number of Participants who Experience TEAEs at 15 Months
Time frame: 15 months
Number of Participants with a Narrowing from Baseline to 6 Months in the Intracranial Nerve Tract in the Cranium and Vault of the Skull
Time frame: Baseline and 6 months
Number of Participants with a Narrowing from Baseline to 12 Months in the Intracranial Nerve Tract in the Cranium and Vault of the Skull
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Derived from this study: PubMed 42470570Bartosik M, Windels O, von Brackel FN, Amling M, Oheim R. Romosozumab in postmenopausal women with classical Osteogenesis imperfecta. Arch Osteoporos. 2026 Jul 18;21(1):100. doi: 10.1007/s11657-026-01744-3.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Related trials for Osteogenesis Imperfecta
RecruitingPhase 2
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
Osteogenesis Imperfecta (OI)
Active, not recruitingObservational study
Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708
Osteogenesis Imperfecta
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Active, not recruitingPhase 3
Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta
Osteogenesis Imperfecta
Active, not recruitingPhase 2/3
Setrusumab vs Placebo for Osteogenesis Imperfecta
Osteogenesis Imperfecta
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.
MD study director
Amgen
65 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Romosozumab and Bisphosphonate in people with Osteogenesis Imperfecta, run by Amgen at 65 sites in 18 countries.
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 10 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, China, Japan, Spain, Poland and 13 more countries. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Clinical Fractures (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT05972551, 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 27 May 2026.