New Bisphosphonate Treatment for Paget's Disease
Summary
HORIZON TOP will study the effect of zoledronic acid given once as an iv infusion compared to 60 days of oral risedronate in patients with Paget's disease of bone. The effect will be demonstrated in the reduction of serum alkaline phosphatase (SAP).
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Paget's Disease of Bone
Intervention
Zoledronic Acid, risedronate
Location
John Wayne Cancer Center
Santa Monica
California
United States
90404
Status
Active, not recruiting
Source
Novartis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00051636
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Paget's Disease, Mammary
An intraductal carcinoma of the breast extending to involve the nipple and areola, characterized clinically by eczema-like inflammatory skin changes and histologically by infiltration of the dermis by malignant cells (Paget's cells). (Dorland, 27th ed)
Carpal Bones
The eight bones of the wrist: SCAPHOID BONE; LUNATE BONE; TRIQUETRUM BONE; PISIFORM BONE; TRAPEZIUM BONE; TRAPEZOID BONE; CAPITATE BONE; and HAMATE BONE.
Fibrous Dysplasia Of Bone
A disease of bone marked by thinning of the cortex and replacement of bone marrow by gritty fibrous tissue containing bony spicules, producing pain, disability, and gradually increasing deformity. Only one bone may be involved (FIBROUS DYSPLASIA, MONOSTOTIC) or several (FIBROUS DYSPLASIA, POLYOSTOTIC). (From Dorland, 28th ed)
Phytanic Acid
A 20-carbon branched chain fatty acid. In phytanic acid storage disease (REFSUM DISEASE) this lipid may comprise as much as 30% of the total fatty acids of the plasma. This is due to a phytanic acid alpha-hydroxylase deficiency.
Flurbiprofen
An anti-inflammatory analgesic and antipyretic of the phenylalkynoic acid series. It has been shown to reduce bone resorption in periodontal disease by inhibiting CARBONIC ANHYDRASE.
Clinical Trials
Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone
The primary objective of this study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response.
Re-treatment of Patients With Paget's Disease Using Zoledronic Acid
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 C...
The purpose of this study is to document the efficacy and safety profiles of single intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget's Disease of Bone (PDB).
The intake of high doses of corticosteroids is known to play an important role in the weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is a drug kn...
Zoledronic acid (Zometa) belongs to a class of drugs called bisphosphonates. Bisphosphonates are used in bone metastases to keep the cancerous lesion under control in the bone and to help...
PubMed Articles
This study summarizes the treatment effect of zoledronic acid infusion on lumbar spine bone mineral density in different subgroups with glucocorticoid-induced osteoporosis. Zoledronic acid is signific...
Although Paget's disease of bone (PDB) is common in western countries, it is extremely rare in Asian ones including Japan. Recently, oral risedronate (17.5 mg once daily) was approved in Japan as a t...
OBJECTIVE:: To evaluate the efficacy of available bisphosphonate therapies regarding the prevention of vertebral, hip, and nonvertebral-nonhip fractures in postmenopausal women with osteoporosis. METH...
Skull involvement in Paget's disease of bone can lead to neurological symptoms, prompting treatment. Intravenous zoledronic acid (ZA) has emerged as an effective and safe treatment option for patients...
Zoledronic Acid in the Treatment of Early-Stage Breast Cancer: Is There a Final Verdict?
Breast cancer, which preferentially metastasizes to bone, is the most common malignancy among women worldwide and is a leading cause of death. Clinical data from large, phase 3 trials (ie, ABCSG-12, Z...
