ZOMETA SUMMARY
Zometa® contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption.
Zometa® (zoledronic acid) Injection is indicated for the treatment of hypercalcemia of malignancy.
Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction of hypovolemia. The safety and efficacy of Zometa in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established.
Zometa is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.
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NEWS HIGHLIGHTS
Published Studies Related to Zometa (Zoledronic Acid)
Intravenous zoledronic acid to prevent osteoporosis in a veteran population with multiple risk factors for bone loss on androgen deprivation therapy. [2009.11]
PURPOSE: Androgen deprivation therapy for prostate cancer is associated with osteoporosis and increased fracture risk. Previous studies of zoledronic acid demonstrated bone loss prevention in patients initiating androgen deprivation therapy. There are limited data on patients on prolonged androgen deprivation therapy or in Veterans Affairs patients with multiple risk factors for osteoporosis... CONCLUSIONS: Zoledronic acid improved bone mineral density in patients with M0 prostate cancer on androgen deprivation therapy for 1 year or less, or greater than 1 year. This finding indicates that bisphosphonate therapy remains effective when initiated later in the course of androgen deprivation therapy and is efficacious in Veterans Affairs patients with multiple risk factors for osteoporosis.
Effect of once-yearly zoledronic acid on the spine and hip as measured by quantitative computed tomography: results of the HORIZON Pivotal Fracture Trial. [2009.10.03]
Changes in bone mineral density and bone strength following treatment with zoledronic acid (ZOL) were measured by quantitative computed analysis (QCT) or dual-energy X-ray absorptiometry (DXA). ZOL treatment increased spine and hip BMD vs placebo, assessed by QCT and DXA. Changes in trabecular bone resulted in increased bone strength. INTRODUCTION: To investigate bone mineral density (BMD) changes in trabecular and cortical bone, estimated by quantitative computed analysis (QCT) or dual-energy X-ray absorptiometry (DXA), and whether zoledronic acid 5 mg (ZOL) affects bone strength... CONCLUSIONS: Once-yearly ZOL increased hip and spine BMD vs placebo, assessed by QCT vs DXA. Changes in trabecular bone resulted in increased indices of compressive strength.
Single infusion of zoledronic acid to prevent androgen deprivation therapy-induced bone loss in men with hormone-naive prostate carcinoma. [2009.08.01]
BACKGROUND: Androgen-deprivation therapy (ADT) decreases bone mineral density (BMD) and increases fracture risk in patients with prostate carcinoma. The authors investigated the effectiveness of a single infusion of zoledronic acid initiated subsequent to ADT on BMD with hormone-naive prostate carcinoma... CONCLUSIONS: Bone loss begins at 6 months with ADT. A single infusion of zoledronic acid in patients receiving ADT reduces bone mineral loss and maintains BMD at least at 12 months during ADT. Further study is needed to determine the best dosing schedule to prevent ADT-induced bone loss in men with hormone-naive prostate carcinoma. Copyright (c) 2009 American Cancer Society.
Antifracture efficacy and reduction of mortality in relation to timing of the first dose of zoledronic acid after hip fracture. [2009.07]
Annual infusions of zoledronic acid (5 mg) significantly reduced the risk of vertebral, hip, and nonvertebral fractures in a study of postmenopausal women with osteoporosis and significantly reduced clinical fractures and all-cause mortality in another study of women and men who had recently undergone surgical repair of hip fracture...
Zoledronic acid effectively prevents aromatase inhibitor-associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole: Z-FAST study 36-month follow-up results. [2009.05]
BACKGROUND: Postmenopausal women with breast cancer receiving adjuvant aromatase inhibitors (AIs) are at risk for accelerated bone loss and subsequent fractures. The ongoing Zometa-Femara Adjuvant Synergy Trial (Z-FAST) is evaluating the efficacy and safety of zoledronic acid in preventing such bone loss... CONCLUSION: Up-front ZA more effectively prevents AI-associated bone loss in postmenopausal women with early breast cancer than delaying therapy until substantial bone loss or fracture occurs.
Clinical Trials Related to Zometa (Zoledronic Acid)
Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older [Active, not recruiting]
Osteoporosis prevention is important in patients with osteopenia (low bone density). This
study will test the safety and efficacy of zoledronic acid in patients diagnosed with
osteopenia.
Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer [Active, not recruiting]
The primary objective of this study is to determine whether zoledronic acid (Zometa) given
once annually increases bone mineral density in men receiving hormone therapy for prostate
cancer.
ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases [Terminated]
To determine if therapy with Zometa® (zoledronic acid) 4mg will be effective in preventing
the occurrence of bone metastases in prostate cancer patients at high risk of developing
them. In addition, pain and analgesic scores and overall safety are to be evaluated
throughout the study.
Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis [Active, not recruiting]
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
mineral density (BMD) gain in the lumbar spine and total hip
Atrasentan and Zometa for Men With Prostate Cancer Metastatic to Bone [Completed]
The main purpose of this study is to look at the effects (good or bad) that Atrasentan given
alone and Atrasentan given with Zometa has on levels of bone formation and bone destruction
in men with prostate cancer that has spread to the bones.
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