Zometa (Zoledronic Acid) - Summary

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)

Fracture risk and zoledronic acid therapy in men with osteoporosis. [2012]
osteoporosis... CONCLUSIONS: Zoledronic acid treatment was associated with a significantly

Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomised, phase 3 trials. [2012]
across three pivotal studies... CONCLUSION: Denosumab was superior to zoledronic acid in preventing SRE with

Prognostic role of serum parathyroid hormone levels in advanced prostate cancer patients undergoing zoledronic acid administration. [2012]
efficacy of these drugs in terms of survival... CONCLUSIONS: Secondary hyperparathyroidism has a negative prognostic impact in

Time to onset of antifracture efficacy and year-by-year persistence of effect of zoledronic acid in women with osteoporosis. [2012]
Oral bisphosphonates reduce fracture risk in osteoporotic patients but are often associated with poor compliance, which may impair their antifracture effects. This post hoc analysis assessed the time to onset and persistence of the antifracture effect of zoledronic acid, a once-yearly bisphosphonate infusion, in women with osteoporosis...

Once-Yearly Zoledronic Acid in Older Men Compared with Women with Recent Hip Fracture. [2011.11]
OBJECTIVES: To assess the efficacy of once-yearly zoledronic acid (ZOL) 5 mg in increasing bone mineral density (BMD) in men with a recent hip fracture participating in the Health Outcomes and Reduced Incidence with Zoledronic Acid Once- Yearly Recurrent Fracture Trial and to compare the efficacy with that in women from the same study... CONCLUSION: Once-yearly IV ZOL 5 mg increases bone mass at the hip and femoral neck in men within 90 days of repair of a low-trauma hip fracture. Increases were of a similar magnitude to those observed in women in the same study. (c) 2011, Copyright the Authors Journal compilation (c) 2011, The American Geriatrics Society.

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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.

Perioperative Treatment With Zoledronic Acid in Patients With Resectable Pancreas Cancer [Recruiting]
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.

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

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Reports of Suspected Zometa (Zoledronic Acid) Side Effects

Osteonecrosis of JAW (3063),  Pain (2193),  Anxiety (1749),  Injury (1250),  Back Pain (1223),  Dyspnoea (1219),  Anaemia (1085),  Exposed Bone in JAW (1084),  Osteomyelitis (1034),  Neoplasm Malignant (1029), more >>