Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta
NCT ID: NCT03638128
Last Updated: 2022-12-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
75 participants
INTERVENTIONAL
2018-07-26
2022-03-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Alternative Medications / Observational
Participants who received non-denosumab alternative therapy during the study or who were not receiving any medication at baseline.
Alternative osteoporosis medication(s) were determined at the investigator's discretion and per standard of care and local guidelines.
Alternative osteoporosis medications
Alternative osteoporosis medication/s at the discretion of the investigator.
Denosumab 1 mg/kg Q6M
Participants who received at least 1 dose of 1 mg/kg denosumab administered once every 6 months (Q6M) by subcutaneous injection, but no Q3M denosumab during this study.
Denosumab
Solution for injection
Denosumab 1 mg/kg Q3M
Participants who received at least one dose of 1 mg/kg denosumab administered once every 3 months (Q3M) by subcutaneous injection during this study.
Denosumab
Solution for injection
Interventions
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Denosumab
Solution for injection
Alternative osteoporosis medications
Alternative osteoporosis medication/s at the discretion of the investigator.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is currently/was enrolled in Study 20130173 and
* completed the 20130173 End of Study (EOS) visit (regardless of completing or ending investigational product early) OR
* did not reconsent/reassent to transition to 3-month dosing regimen on Study 20130173 OR
* early terminated from Study 20130173 as a result of meeting bone mineral density (BMD) Z-score investigational product stopping criteria.
Exclusion Criteria
* Subjects currently receiving treatment in another investigational device or drug study other than Study 20130173. Other investigational procedures while participating in this study are excluded.
* For subjects expected to receive investigational product (denosumab) at study day 1: Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 months after the last dose of denosumab. Females of childbearing potential (Tanner Stage greater than or equal to 2) should only be included in the study after a negative highly sensitive urine or serum pregnancy test. For study treatment with alternative osteoporosis medication/s of investigator's choice, follow guidelines per the specific alternative osteoporosis medication/s selected. For Subjects off-treatment (observation only), no exclusion applies.
* For subjects expected to receive investigational product (denosumab) at study day 1: Female subjects of childbearing potential unwilling to practice true sexual abstinence (refrain from heterosexual intercourse) or use 1 highly effective method of contraception during treatment and for an additional 5 months after the last dose of investigational product (denosumab). For study treatment with alternative osteoporosis medication/s of investigator's choice, follow contraception guidelines per the specific alternative osteoporosis medication/s selected. For subjects not receiving any investigational product (observation only), no contraception required.
* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Childrens Hospital of Los Angeles
Los Angeles, California, United States
Indiana University - Riley Hospital for Children
Indianapolis, Indiana, United States
The Childrens Hospital at Westmead
Westmead, New South Wales, Australia
Perth Childrens Hospital
Nedlands, Western Australia, Australia
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, , Belgium
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Shriners Hospital for Children
Montreal, Quebec, Canada
Fakultni nemocnice Plzen
Pilsen, , Czechia
Thomayerova nemocnice
Prague, , Czechia
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux, , France
Hopital Necker Enfants Malades
Paris, , France
Uniklinik Köln
Cologne, , Germany
Semmelweis Egyetem
Budapest, , Hungary
Azienda Ospedaliera Policlinico Umberto I
Roma, , Italy
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain
Birmingham Childrens Hospital
Birmingham, , United Kingdom
Bristol Royal Hospital for Children
Bristol, , United Kingdom
Royal Hospital for Children
Glasgow, , United Kingdom
Sheffield Childrens Hospital
Sheffield, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2018-000550-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20170534
Identifier Type: -
Identifier Source: org_study_id