NEWS HIGHLIGHTS
Published Studies Related to Reclast (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 Reclast (Zoledronic Acid)
Neoadjuvant Zoledronic Acid in Patients With Resectable Pancreas Cancer [Not yet 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 on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Ablation Therapy [Recruiting]
The purpose of this research is to determine the effect of timing of Zometa® administration
on bone mineral density of the lumbar spine and femoral neck in men undergoing androgen
deprivation therapy for prostate adenocarcinoma. In addition, the researchers will also
determine the effects of treatment with Zometa® on peripheral blood markers of bone
turnover, on peripheral blood gd T-cell frequencies and function, and to determine if the
above treatments elicit prostate antigen-specific IgG immune responses. The effects of the
above treatments on serial serum PSA measurements will also be examined.
Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis [Recruiting]
Primary Objectives:
Phase I:
- To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for
dasatinib in combination with zoledronic acid.
Phase II:
- Determine the efficacy of dasatinib in combination with zoledronic acid using
reductions in N-telopeptide of Type I Collagen (Ntx) as the measure of therapeutic
response.
Secondary Objectives:
Phase I:
- To determine toxicity of combination therapy with dasatinib and zoledronic acid in
patients with breast cancer and bone metastasis.
Phase II:
- Changes in Ntx levels will be correlated with traditional measurements of tumor
response in bone (using WHO criteria), progression free survival and overall survival
at 2 years
- Biologic characterization of response using 18F-FDG PET
- Determination of molecular correlates of response in paraffin embedded or frozen tissue
- Determine time to tumor progression, response, time to tumor response, progression free
survival (PFS) up to 2 years
- Determine overall survival (OS) at 2 years
- Banking of blood for future studies of novel markers of bone health
- Correlate response with tumor estrogen receptor (ER), progesterone receptor (PR) and
HER2 status
Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss [Recruiting]
Primary Objective:
- Evaluate the effect of zoledronate on change in BMD at the total lumbar spine and femoral
neck.
Secondary Objectives:
- Evaluate the effect of zoledronate on change in BMD at the total hip.
- Evaluate risk factors for developing osteoporosis on chemotherapy.
- Determine correlative markers for response to zoledronate.
- Evaluate zoledronate effect on new bone fractures.
- Evaluate the cost-effectiveness of zoledronic acid (with calcium and vitamin D) versus
standard treatment (calcium and vitamin D alone).
Zometa and Circulating VEGF in Breast Cancer Patients With Bone Metastasis [Recruiting]
The primary objective of this study is to evaluate the effects of Zometa (zoledronic acid, 1
mg per week versus 4 mg every four weeks) on the circulating vascular endothelial growth
factor (VEGF) levels in breast cancer patients with bone metastases. Sixty patients will be
randomized into two groups.
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