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)
Delaying skeletal-related events in a randomized phase 3 study of denosumab
versus zoledronic acid in patients with advanced cancer: an analysis of data from
patients with solid tumors. [2014] myeloma... CONCLUSIONS: Denosumab was more effective in delaying or preventing SREs in
Reduction in the risk of clinical fractures after a single dose of zoledronic
Acid 5 milligrams. [2013] 1 infusion of zoledronic acid... CONCLUSIONS: In this post hoc analysis based on postrandomization subgroups,
Clinical significance of zoledronic acid and strontium-89 in patients with
asymptomatic bone metastases from non-small-cell lung cancer. [2013] lung cancer (NSCLC) with asymptomatic bone metastases (BMs)... CONCLUSIONS: Treatment with ZA and/or Sr-89 significantly extended the time to
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
Clinical Trials Related to Reclast (Zoledronic Acid)
Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast® [Completed]
This study will evaluate the impact of investigator and patient education and educational
materials to foster calcium and vitamin D supplementation to mitigate the potential for
hypocalcemia post Reclast® administration in patients with Paget's disease of bone.
PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer [Active, not 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.
The Use of Zoledronic Acid to Complex Regional Pain Syndrome [Not yet recruiting]
Perioperative Treatment With Zoledronic Acid in Patients With Resectable Pancreas Cancer [Terminated]
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.
Zoledronic Acid Administration in Acute Spinal Cord Injury [Completed]
In subjects with acute SCI: To compare the effects of parenteral zoledronic acid therapy on
preservation of regional and total skeletal mass (DXA).
Hypothesis: Zoledronic acid will dramatically diminish bone loss in persons with acute SCI,
as evidenced by serial densitometry determinations (DXA).
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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