RECLAST SUMMARY
Reclast contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption.
Reclast (zoledronic acid) is indicated for the following:
Postmenopausal Osteoporosis
Reclast is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, Reclast reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures) [ see Clinical Studies (14 .1)].
Paget's Disease of Bone
Reclast is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [ see Clinical Studies (14 . 2 ) ].
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NEWS HIGHLIGHTS
Published Studies Related to Reclast (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.
Clinical Trials Related to Reclast (Zoledronic Acid)
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.
Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year [Recruiting]
The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK)
profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in
patients treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.
Re-treatment of Patients With Paget's Disease Using Zoledronic Acid [Recruiting]
The purpose of this study is to demonstrate that patients with Paget's disease of the bone
who had responded to zoledronic acid treatment as participants in the core registration
studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully
treated with a 5mg infusion of zoledronic acid.
PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer [Recruiting]
The primary goal for this trial is to assess the change in PET scans with the administration
of zoledronate (bisphosphonate) therapy in patients with metastatic prostate cancer. It
has been established that zoledronate therapy may play a role in delaying and reducing the
incidence of skeletal events. Researchers propose to evaluate the change in the uptake
value of FMAU PET scan after the zoledronate therapy. It has been demonstrated that FMAU
PET scans can successfully demonstrate and detect bony metastatic sites in prostate cancer.
In addition, investigators would like to evaluate the change in the level of the
prostate-specific antigen (PSA) in the patient as well as outcome of bone scans.
Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients [Recruiting]
This study will evaluate zoledronic acid's anti-cancer effects and Circulating Tumor Cell
(CTCs) measurements in patients with HER2-negative metastatic breast cancer without bone
metastasis.
Reports of Suspected Reclast (Zoledronic Acid) Side Effects
Death (377),
Pain (226),
Arthralgia (210),
Femur Fracture (154),
Fall (153),
Headache (137),
Pain in Extremity (133),
Nausea (121),
Pyrexia (114),
Myalgia (113), more >>
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