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A Prospective Multicentre Phase II Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)

2014-07-23 21:46:18 | BioPortfolio

Summary

In this trial, the question is addressed if zoledronic acid (Zometa, Novartis Pharma)could be of clinical benefit for patients with myelofibrosis and myeloid metaplasia (MMM).

Description

This is a prospective, multicentre phase II study in adult patients with documented MMM and requiring therapy for their disease. Patients will be treated every 3 weeks with 4 mg zoledronic acid (Zometa®), administered by a 15 min. intravenous infusion. Study duration is 36 weeks (12 infusions). After the study it is recommended to continue treatment until disease progression, or the occurrence of unacceptable treatment-related toxicity.

Objectives of the trial are:

Primary objectives

The primary objectives of this study are to evaluate in patients with myelofibrosis:

- the effect of Zometa® on hemoglobin level

- the effect of Zometa® acid on spleen size

- the safety of Zometa®

Secondary objectives

The secondary objectives of this study are to evaluate in patients with myelofibrosis the effect of Zometa® on:

- red blood cell transfusion need

- performance status and constitutional symptoms

- leukocyte/thrombocyte count

- bone marrow histology, i.e. reticulin fibrosis, collagen fibrosis, osteosclerosis and angiogenesis

- serum LDH

- cytogenetics i.e. clonal evolution or regression

- bone remodelling

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Myelofibrosis

Intervention

zoledronic acid

Location

Cancer Care Services
Brisbane
Queensland
Australia
4029

Status

Recruiting

Source

University Hospital, Gasthuisberg

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:46:18-0400

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The overall purpose of this research is to evaluate the safety and side effects of zoledronic acid (also known as Zometa) in patients before they have surgery to remove the cancer.

Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis

The purpose of this study is to assess the effects of zoledronic acid administered at the same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone mine...

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Efficacy of Zoledronic Acid in Osteoporosis

There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis.

Safety and Efficacy Study of Concomitant Radiotherapy and Zoledronic Acid for Bone Metastases Palliation

Zoledronic acid (Zometa) belongs to a class of drugs called bisphosphonates. Bisphosphonates are used in bone metastases to keep the cancerous lesion under control in the bone and to help ...

PubMed Articles [6551 Associated PubMed Articles listed on BioPortfolio]

Effects of Zoledronic Acid in Experimental Periapical Lesions in Rats: An Imaging and Histological Analysis.

The aim of this study was to assess the imaging and histological features of experimental periapical lesions, including the adjacent alveolar bone, in rats under zoledronic acid treatment. The study u...

Response to Cost-Effectiveness Analysis of Zoledronic Acid Once Per Month, Zoledronic Acid Once Every 3 Months, and Denosumab Once Per Month in Women With Breast Cancer and Skeletal Metastases.

Epigallocatechin-3-gallate reduces damage to osteoblast-like cells treated with Zoledronic acid.

analyze the effect of zoledronic acid (ZA) alone and in combination with epigallocatechin-3-gallate (EGCG) on human osteoblast cells.

ZOLEDRONIC ACID VERSUS ALENDRONATE IN THE TREATMENT OF CHILDREN WITH OSTEOGENESIS IMPERFECTA: A 2-YEAR CLINICAL STUDY.

Bisphosphonates have been demonstrated to increase the bone mineral density (BMD) of osteogenesis imperfecta (OI) patients. We aimed to compare the efficacy and safety of intravenous zoledronic acid a...

Micro-CT evaluating inhibitory effect of zoledronic acid on polyethylene particle-induced periprosthetic osteolysis model.

To observe inhibitory effect of zoledronic acid on polyethylene particle-induced periprosthetic osteolysis model.

Medical and Biotech [MESH] Definitions

A de novo myeloproliferation arising from an abnormal stem cell. It is characterized by the replacement of bone marrow by fibrous tissue, a process that is mediated by CYTOKINES arising from the abnormal clone.

An acute myeloid leukemia in which 20-30% of the bone marrow or peripheral blood cells are of megakaryocyte lineage. MYELOFIBROSIS or increased bone marrow RETICULIN is common.

A myeloproliferative disorder of unknown etiology, characterized by abnormal proliferation of all hematopoietic bone marrow elements and an absolute increase in red cell mass and total blood volume, associated frequently with splenomegaly, leukocytosis, and thrombocythemia. Hematopoiesis is also reactive in extramedullary sites (liver and spleen). In time myelofibrosis occurs.

Carbonic acid (H2C03). The hypothetical acid of carbon dioxide and water. It exists only in the form of its salts (carbonates), acid salts (hydrogen carbonates), amines (carbamic acid), and acid chlorides (carbonyl chloride). (From Grant & Hackh's Chemical Dictionary, 5th ed)

A 20-carbon-chain fatty acid, unsaturated at positions 8, 11, and 14. It differs from arachidonic acid, 5,8,11,14-eicosatetraenoic acid, only at position 5.

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