Osteogenesis ImperfectaPhase 2MeteoroidNCT03216486
An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
A Phase 2 study testing BPS804 in people with Osteogenesis Imperfecta, run by Ultragenyx Pharmaceutical Inc at 2 sites in United States.
Trial summary
The purpose of this study is to investigate the effect of BPS804 on strength/quality of bone in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT scanner. Participants will be treated for 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- BPS804
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2017to 1 Nov 2018
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a clinical diagnosis of OI Type I, III or IV
- Capable of giving signed consent
Who cannot join
- History of skeletal malignancies or other bone diseases (other than OI)
- History of endocrine or thyroid/parathyroid conditions that could affect bone metabolism
- Treatment with bisphosphonates within 3 months of randomisation
- Treatment with teraparatide, denosomab or other anabolic/antiresorbative medications within 6 months of randomisation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mereo Investigator Site
Albuquerque, New Mexico, 87106
Mereo Investigator Site
Houston, Texas, 77030
About this study
Official title: A Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
The purpose of this study is to investigate the effect of BPS804 on strength/quality of bone in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT scanner. Participants will be treated for 1 year.
Read the detailed description
This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in February 2021.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- BPS804
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPS804Drug
IV administration of BPS804 in 5% Dextrose solution
| Study group | Role | What they receive |
|---|---|---|
| BPS804 Dose 1 | Experimental | BPS804 IV Infusion Receives: Drug: BPS804 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)
High Resolution Peripheral Quantitative Computated Tomography
Measured: 12 months
Change in radial bone strength on Finite Element Analysis (N)
High Resolution Peripheral Quantitative Computated Tomography
Measured: 12 months
Secondary outcomes (2)
Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)
High Resolution Peripheral Quantitative Computated Tomography
Measured: 12 months
Change in tibial bone strength on Finite Element Analysis (N)
High Resolution Peripheral Quantitative Computated Tomography
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start31 Oct 2017 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Why it stopped: Administrative Reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by Ultragenyx Pharmaceutical IncThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open-label
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ultragenyx Pharmaceutical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mereo BioPharma
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Ultragenyx Pharmaceutical Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216486
- Sponsor's protocol ID
- MBPS208
- Acronym
- Meteoroid
- Status last verified
- Jun 2023
- First submitted
- 12 Jul 2017
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
- ClinicalTrials.gov ID
- NCT03216486
- Acronym / sponsor ID
- Meteoroid / MBPS208
- Conditions
- Osteogenesis Imperfecta
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative Reason
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ultragenyx Pharmaceutical IncIndustry (pharma, biotech, devices)
- Collaborators
- Mereo BioPharma
- Study start
- 31 Oct 2017 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 13 Jul 2017 (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 purpose of this study is to investigate the effect of BPS804 on strength/quality of bone in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT scanner. Participants will be treated for 1 year.
Detailed description
This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in February 2021.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open-label
| Arm | Type | Receives |
|---|---|---|
| BPS804 Dose 1 | Experimental | Drug: BPS804BPS804 IV Infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a clinical diagnosis of OI Type I, III or IV
- Capable of giving signed consent
Key exclusion criteria (4 listed)
- History of skeletal malignancies or other bone diseases (other than OI)
- History of endocrine or thyroid/parathyroid conditions that could affect bone metabolism
- Treatment with bisphosphonates within 3 months of randomisation
- Treatment with teraparatide, denosomab or other anabolic/antiresorbative medications within 6 months of randomisation
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 |
|---|---|---|
| BPS804IV administration of BPS804 in 5% Dextrose solution | Drug | BPS804 Dose 1 |
Primary outcome
Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)
Time frame: 12 months
High Resolution Peripheral Quantitative Computated Tomography
Change in radial bone strength on Finite Element Analysis (N)
Time frame: 12 months
High Resolution Peripheral Quantitative Computated Tomography
2 secondary outcomes
Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)
Time frame: 12 months
Change in tibial bone strength on Finite Element Analysis (N)
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
Related trials for Osteogenesis Imperfecta
RecruitingPhase 2
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
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Active, not recruitingObservational study
Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708
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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.
Medical Director study director
Ultragenyx Pharmaceutical Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BPS804 in people with Osteogenesis Imperfecta, run by Ultragenyx Pharmaceutical Inc at 2 sites in United States.
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 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: withdrawn, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2023.