Denosumab Follow-up Study in Patients with Giant Cell Tumour of Bone
Research type
Research Study
Full title
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004.
IRAS ID
232401
Contact name
Michael Parry
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2017-001758-32
Duration of Study in the UK
6 years, 0 months, 6 days
Research summary
This prospective study will provide long term safety follow up for participants who complete 20062004 study and consent to be enrolled in study 20140114.
The participants’s follow up begins after signing the informed consent form and continues through to the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow up.
Study assessments are to be completed every 6 months (± 30 days).
Participants who are still being treated with denosumab when 20062004 completes can continue receiving open label denosumab at dose of 120 mg subcutaneously every 4 weeks.
Collection of long term safety information will include the following adverse events of interest: osteonecrosis of the jaw, malignancy (including malignancy in GCTB), atypical femoral fracture, severe symptomatic hypocalcemia, symptomatic hypercalcemia following treatment discontinuation, and pregnancy and lactation (if occurring on treatment or within 5 months of last dose of denosumab). Additionally, all treatment emergent adverse events and serious adverse events will be collected.
All participants receiving denosumab should be adequately supplemented with calcium and vitamin D (at least 500 mg of calcium and 400 IU of vitamin D), except in the case of pre existing hypercalcemia.Participants who completed denosumab treatment in 20062004 and were in the safety follow up at the conclusion of 20062004 will continue in long term safety follow up in this study.
Follow up study visits will take place every 6 months (± 30 days) either via telephone or in person clinic visit.
Retreatment with denosumab (120 mg subcutaneous [SC] every 4 weeks) is allowed for participants who previously demonstrated a response to denosumab and have experienced disease recurrence while in long-term safety follow up. If more than 12 months have elapsed since the last denosumab therapy, biopsy confirmation of disease for further pathologic evaluation of the recurrence is required.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0569
Date of REC Opinion
15 Jan 2018
REC opinion
Further Information Favourable Opinion