Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta

Phase 1

• Conditions: Osteogenesis Imperfecta (OI); MedDRA version: 20.0Level: PTClassification code 10031243Term: Osteogenesis imperfectaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-000550-21-GB
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-17
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Subjects are eligible to be included in the study only if all of the
following criteria apply:
-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 was enrolled in Study 20130173 and:
? - completed the 20130173 EOS visit (regardless of completing or ending investigational product early).
OR
?- Subjects who do not reconsent to transition to 3-Month Dosing regimen on Study 20130173 are also eligible for enrollment
OR
? Early terminated from Study 20130173 as a result of meeting BMD Z-score IP stopping criteria and was required to early terminate from the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 114
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects are excluded from the study if any of the following criteria apply:
Prior/Concomitant Therapy
-Treatment with any prohibited proscribed medications during Study 20130173while 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.
Prior/Concurrent Clinical Study Experience
-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.
Other Exclusions
-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 = 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 (IP) (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 IP (observation only), no contraception required. Refer to Appendix 1 for additional contraceptive information.
-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified