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Trial record 1 of 6 for:    BPS804
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An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta (METEOROID)

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ClinicalTrials.gov Identifier: NCT03216486
Recruitment Status : Withdrawn (Administrative Reason)
First Posted : July 13, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Mereo BioPharma

Tracking Information
First Submitted Date  ICMJE July 12, 2017
First Posted Date  ICMJE July 13, 2017
Last Update Posted Date December 22, 2017
Estimated Study Start Date  ICMJE October 31, 2017
Estimated Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03216486 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
  • Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3) [ Time Frame: 12 months ]
    High Resolution Peripheral Quantitative Computated Tomography
  • Change in tibial bone strength on Finite Element Analysis (N) [ Time Frame: 12 months ]
    High Resolution Peripheral Quantitative Computated Tomography
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
Official Title  ICMJE A Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Single arm, open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteogenesis Imperfecta
Intervention  ICMJE Drug: BPS804
IV administration of BPS804 in 5% Dextrose solution
Study Arms  ICMJE Experimental: BPS804 Dose 1
BPS804 IV Infusion
Intervention: Drug: BPS804
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 21, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2017)
10
Estimated Study Completion Date  ICMJE November 1, 2018
Estimated Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with a clinical diagnosis of OI Type I, III or IV
  • Capable of giving signed consent

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03216486
Other Study ID Numbers  ICMJE MBPS208
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mereo BioPharma
Study Sponsor  ICMJE Mereo BioPharma
Collaborators  ICMJE ICON Clinical Research
Investigators  ICMJE
Principal Investigator: Reid Sutton, Prof. Baylor College of Medicine
PRS Account Mereo BioPharma
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP