Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI

Stopped early · Phase 3

Conditions studied: Osteogenesis Imperfecta

In brief

This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.

Key facts

Study ID

NCT02352753

Run by

Amgen

People needed

153

Starts

2015-06-24

Expected to finish

2022-03-26

Last updated by the study team

2022-12-28

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of OI defined as a clinical history consistent with type I-IV OI Clinical severity of OI as defined by 2 or more prevalent vertebral compression fractures; OR1 prevalent vertebral compression fracture and 1 or more nonvertebral fractures within the previous 2 years; OR 3 or more fractures within the previous 2 years.

You may not qualify if…

• Inability or unwillingness to comply with the requirements for frequent calcium and phosphorus monitoring for 14 days after the first dose of denosumab (only applies to the first 5 subjects age 11 to17 enrolled in the study and the first 5 subjects of any age meeting the criteria for increased bone turnover
• Currently unhealed fracture or osteotomy as defined by orthopedic opinion
• Osteotomy within 5 months of screening
• Evidence of untreated oral cavities or oral infections
• Recent or planned invasive dental procedure
• Surgical tooth extraction which has not healed by screening
• History of an electrophoresis pattern inconsistent with type I to IV OI
• History of genetic testing results inconsistent with type I to IV OI
• Abnormalities of the following per central laboratory reference ranges at screening: Serum albumin corrected calcium < lower limit of normal (LLN) Serum vitamin D < 20 ng/mL; re-screening for Vitamin D level < 20 ng/mL will be allowed, after adequate supplementation
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 1.5 x upper limit of normal (ULN)
• Total bilirubin (TBL) > 1.5 x ULN (subjects with Gilbert syndrome are eligible)
• Serum phosphorus < LLN
• Serum alkaline phosphatase > 20% above the ULN or > 20% below the LLN
• Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (calculated bythe Schwartz equation at screening) Evidence of any of the following: Current hyperthyroidism (unless well-controlled on stable antithyroid therapy)
• Current clinical hypothyroidism (unless well-controlled on stable thyroid replacement therapy)
• History of hyperparathyroidism
• Current hypoparathyroidism
• Current, uncontrolled hypercalcemia (albumin-corrected serum Ca >10% ULN)
• History of osteomalacia or rickets (chart review)
• Other bone diseases that affect bone metabolism (eg, osteoporosis pseudoglioma syndrome, idiopathic juvenile osteoporosis, osteopetrosis, hypophosphatasia)
• History of autoimmune disease
• History of rare hereditary problems of fructose intolerance
• Positive blood screen for human immunodeficiency virus -1 or -2 antibody
• Positive blood screen for hepatitis B surface antigen or hepatitis C antibody
• Received other osteoporosis treatment or bone active treatment with the following guidelines:

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — Torrance, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Wilmington, Delaware, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Iowa City, Iowa, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Houston, Texas, United States
• Research Site — Westmead, New South Wales, Australia
• Research Site — Subiaco, Western Australia, Australia
• Research Site — Brussels, Belgium
• Research Site — Ghent, Belgium
• Research Site — Leuven, Belgium
• Research Site — Sofia, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Varna, Bulgaria
• Research Site — Ottawa, Ontario, Canada
• Research Site — Toronto, Ontario, Canada
• Research Site — Montreal, Quebec, Canada
• Research Site — Hradec Králové, Czechia

Full record on ClinicalTrials.gov

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