This study is currently not recruiting participants.

Multicenter, Single-arm, Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta

Investigating Long-Term Safety and Efficacy of an Investigational Medication in Osteogenesis Imperfecta

Not Recruiting
100 years or below
All

Brief description of study.

This study 20170534 is an open-label extension of study 20130173 to assess long-term safety and efficacy of current or prior treatment with denosumab in children/young adults with osteogenesis imperfecta (OI).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Osteogenesis Imperfecta
  • Age: 100 years or below
  • Gender: All

Inclusion Criteria

Currently/was enrolled in Study 20130173 and completed the month 36 visit.

Exclusion Criteria

Treatment with any prohibited proscribed medications during Study 20130173

Currently receiving treatment in another investigational device or drug study other than Study 20130173.  Other investigational procedures while participating in this study are excluded.

Pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 months after the last dose of denosumab

Female participants 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)

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.

This study investigates the long-term safety and effectiveness of an investigational medication in children and young adults with osteogenesis imperfecta, a condition that causes fragile bones. The study is an extension of a previous study and aims to understand the ongoing effects of the treatment.

Participants will continue to receive the investigational medication and will undergo regular health assessments to monitor safety and effectiveness. The study will include various procedures to evaluate the impact of the medication on bone strength and overall health.

  • Who can participate: Eligible participants are children and young adults who completed the previous study and reached the month 36 visit. They must not be involved in other investigational studies or have taken prohibited medications during the prior study.
  • Study details: Participants will receive the investigational medication and undergo health assessments. No placebo will be used in this study.
Updated on 19 Feb 2024. Study ID: 1809335366

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