Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone

Официальное название

Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial

Обзор

The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone coming back to the same location. The hypothesis is that the local administration of bisphosphonate will decrease the rate of the tumor returning compared to traditional aggressive surgical removal of the tumor.

Подробное описание

The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate (BP-loaded PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will evaluate whether bisphosphonate as a surgical adjuvant improves secondary outcomes, such as pain, function, fever, or wound complications. The hypothesis is that the local administration of bisphosphonate will decrease the recurrence rate of GCT compared to traditional aggressive intralesional curettage.

Вмешательства

• Препарат Zoledronic Acid
  4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement

Первичные конечные точки

• The endpoint for patient participation will be local recurrence [Срок оценки: Followed for 2 years postoperatively for study end points]

Вторичные конечные точки (4)

• MSTS Score [Срок оценки: Followed for 2 years postoperatively for study end points]
• Surgical site infection [Срок оценки: Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery.]
• Wound healing [Срок оценки: Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery.]
• Potential bisphosphonate complications related to systemic administration [Срок оценки: Followed for 2 years postoperatively for study end points]

Критерии участия

Критерии включения

• Primary benign GCT of bone
• Lesion located in an extremity
• Lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal
• No previous systemic bisphosphonate or denosumab therapy

Критерии исключения

• Recurrent GCT of bone
• Non-extremity location
• Lesion too extensive for intralesional treatment, either due to bone loss, joint invasion, or large soft tissue component
• Children and pregnancy
• Previous systemic bisphosphonate or denosumab therapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 14 центров

• University of California - Los Angeles — Los Angeles
• Indiana University — Indianapolis
• University of Iowa — Iowa City
• University of Kansas — Overland Park
• Johns Hopkins University Hospital — Baltimore
• Massachusetts General Hospital — Boston
• Boston Children's Hospital — Boston
• Beth Israel Deaconess Medical Center — Boston
• … и ещё 6 центров

Канада · 1 центр

• McGill University Health Centre — Montreal

Индия · 1 центр

• All India Institute of Medical Science — New Delhi

Идентификаторы

NCT: NCT03295981 · 28229

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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