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Double-Blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)

2014-08-27 03:51:54 | BioPortfolio

Summary

This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 study (HORIZON Pivotal Fracture Trial).

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Osteoporosis

Intervention

Zoledronic Acid, Placebo, Zoledronic acid

Location

Southern Arizona VA
Tucson
Arizona
United States
85723

Status

Active, not recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:51:54-0400

Clinical Trials [3107 Associated Clinical Trials listed on BioPortfolio]

Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis

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 mine...

Neoadjuvant Zoledronic Acid in Patients With Resectable Pancreas Cancer

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.

Efficacy of Zoledronic Acid in Osteoporosis

There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis.

Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis

This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteop...

Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older

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.

PubMed Articles [11319 Associated PubMed Articles listed on BioPortfolio]

Epigallocatechin-3-gallate reduces damage to osteoblast-like cells treated with Zoledronic acid.

analyze the effect of zoledronic acid (ZA) alone and in combination with epigallocatechin-3-gallate (EGCG) on human osteoblast cells.

Novel bisphosphonates with antiresorptive effect in bone mineralization and osteoclastogenesis.

Bisphosphonates such as zoledronic, alendronic and risedronic acids are a class of drugs clinically used to prevent bone density loss and osteoporosis. Novel P-C-P bisphosphonates were synthesized for...

Prevention of breast cancer treatment-induced bone loss in premenopausal women treated with zoledronic acid: Final 5-year results from the randomized, double-blind, placebo-controlled ProBONE II trial.

Premenopausal women receiving chemotherapy or endocrine treatment for early breast cancer are at increased risk for cancer treatment induced bone loss (CTIBL). The aim of the randomized, double-blind ...

Zoledronic Acid Induces Site-Specific Structural Changes and Decreases Vascular Area in the Alveolar Bone.

The aim was to assess the effect of a relevant regimen of zoledronic acid (ZA) treatment for the study of bisphosphonate-related osteonecrosis of the jaw on alveolar bone microstructure and vasculatur...

Predictors of Skeletal-Related Events among Cancer Patients with Bone Metastases Treated with Zoledronic Acid: a Secondary Analysis of a Randomized Study.

The purpose of the current study is to assess the predictors of skeletal-related events (SREs) among advanced cancer patients with bone metastases treated with zoledronic acid within a randomized stud...

Medical and Biotech [MESH] Definitions

Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.

Carbonic acid (H2C03). The hypothetical acid of carbon dioxide and water. It exists only in the form of its salts (carbonates), acid salts (hydrogen carbonates), amines (carbamic acid), and acid chlorides (carbonyl chloride). (From Grant & Hackh's Chemical Dictionary, 5th ed)

A 20-carbon-chain fatty acid, unsaturated at positions 8, 11, and 14. It differs from arachidonic acid, 5,8,11,14-eicosatetraenoic acid, only at position 5.

A dicarboxylic acid ketone that is an important metabolic intermediate of the CITRIC ACID CYCLE. It can be converted to ASPARTIC ACID by ASPARTATE TRANSAMINASE.

An aminobisphosphonate derivative of etidronic acid and CALCIUM CHANNEL BLOCKER that inhibits BONE RESORPTION and is used for the treatment of OSTEOPOROSIS.

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