Phase
Condition
Bone Diseases
Musculoskeletal Diseases
Severe Short Stature
Treatment
BMN 111
Clinical Study ID
Ages > 6 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must have completed Study 111-301
Female >= 10 years old or who have begun menses must have a negative pregnancy testat the Baseline Visit and be willing to have additional pregnancy tests during thestudy
If sexually active, willing to use a highly effective method of contraception whileparticipating in the study
Are willing and able to perform all study procedures
Parent(s) or guardian(s) are willing and able to provide written, signed informedconsent after the nature of the study has been explained and prior to performance ofany research-related procedure. Also, subjects under the age of majority are willingand able to provide written assent (if required by local regulations or the IRB/IEC)after the nature of the study has been explained and prior to performance of anyresearch-related procedure. Subjects who reach the age of majority in their countrywhile the study is ongoing will be asked to provide their own written consent againupon reaching the legal age of majority.
Exclusion
Exclusion Criteria:
Permanently discontinued BMN 111 or placebo prior to completion of the 111-301 study
Have a clinically significant finding or arrhythmia on Baseline ECG that indicatesabnormal cardiac function
Evidence of decreased growth velocity (<1.5 cm/year) as assessed over a period of atleast 6 months or of growth plate closure (proximal tibia, distal femur) throughbilateral lower extremity X-rays.
Require any investigational agent prior to completion of study period
Current therapy with medications known to alter renal function
Pregnant or breastfeeding or plan to become pregnant during study
Concurrent disease or condition that, in the view of the investigator, wouldinterfere with study participation or safety evaluations, for any reason.
Have a condition or circumstance that, in the view of the investigator, places thesubject at high risk for poor treatment compliance or for not completing the study.
Study Design
Connect with a study center
The Children's Hospital at Westmead
Westmead, New South Wales 2145
AustraliaSite Not Available
Murdoch Children's Research Institute
Parkville, Victoria 3052
AustraliaSite Not Available
Otto-von-Gericke Universitaet, Universitaetskinderklinik
Magdeburg, 39120
GermanySite Not Available
Universitätsklinikum Münster
Münster, 48149
GermanySite Not Available
Osaka University Hospital
Osaka,
JapanSite Not Available
Saitama Children's Medical Center
Saitama,
JapanSite Not Available
Tokushima University Hospital
Tokushima,
JapanSite Not Available
Hospital Sant Joan de Deu
Barcelona, 08950
SpainSite Not Available
Institut Catala de Traumatologica I Medicina de l'Esport
Barcelona, 08028
SpainSite Not Available
Hospital Universitario Virgen de la Victoria
Málaga, 29010
SpainSite Not Available
Acibadem University School of Medicine
Istanbul, 34752
TurkeySite Not Available
Acibadem University School of Medicine
Istanbul, 34752
Turkey (Türkiye)Site Not Available
Guy's and St. Thomas NHS Foundation Trust Evelina Children's Hospital
London, SE1 9RT
United KingdomSite Not Available
Sheffield Children's NHS Foundation Trust
Sheffield, S10 2TH
United KingdomSite Not Available
Children's Hospital & Research Center Oakland
Oakland, California 94609
United StatesSite Not Available
Harbor - UCLA Medical Center
Torrance, California 90509
United StatesSite Not Available
Alfred I. duPont Hospital for Children
Wilmington, Delaware 19803
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Johns Hopkins University
Baltimore, Maryland 21287
United StatesSite Not Available
University of Missouri
Columbia, Missouri 65201
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available
Medical College of Wisconsin, Children's Hospital
Milwaukee, Wisconsin 53226
United StatesSite Not Available

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