Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta
Condition: Osteogenesis Imperfecta (OI)
MeSH terms: Osteogenesis Imperfecta
Intervention: Denosumab; Alternative osteoporosis medications
Intervention description: Solution for injection; Alternative osteoporosis medication/s at the discretion of the investigator.
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Healthy volunteers: No
Keywords: OI; Bone.

Summary:

      To evaluate long-term safety of denosumab in children/young adults with pediatric
      osteogenesis imperfecta (OI) who completed the prior study 20130173 (NCT02352753).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent/assent prior to initiation of any Study 20170534
             specific activities/procedures. Subject's legally acceptable representative has
             provided informed consent when the subject is legally too young to provide informed
             consent and the subject has provided written assent based on local regulations and/or
             guidelines prior to any study-specific activities/procedures being initiated.

          -  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:

          -  Treatment with any prohibited proscribed medications while receiving denosumab.
             Eligibility into 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 prohibited
             medications apply.

          -  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.