Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis
Summary
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 mineral density (BMD) gain in the lumbar spine and total hip
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Osteoporosis
Intervention
Zoledronic acid placebo plus teriparatide, Zoledronic acid, Zoledronic acid plus teriparatide
Location
Novartis Investigative Site
Birmingham
Alabama
United States
35294
Status
Active, not recruiting
Source
Novartis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00439244
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Teriparatide
A polypeptide that consists of the 1-34 amino-acid fragment of human PARATHYROID HORMONE, the biologically active N-terminal region. The acetate form is given by intravenous infusion in the differential diagnosis of HYPOPARATHYROIDISM and PSEUDOHYPOPARATHYROIDISM. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
Carbonic Acid
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)
8,11,14-eicosatrienoic Acid
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.
Oxalic Acid
A strong dicarboxylic acid occurring in many plants and vegetables. It is produced in the body by metabolism of glyoxylic acid or ascorbic acid. It is not metabolized but excreted in the urine. It is used as an analytical reagent and general reducing agent.
Uridine Diphosphate Glucuronic Acid
A nucleoside diphosphate sugar which serves as a source of glucuronic acid for polysaccharide biosynthesis. It may also be epimerized to UDP iduronic acid, which donates iduronic acid to polysaccharides. In animals, UDP glucuronic acid is used for formation of many glucosiduronides with various aglycones.
Clinical Trials
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.
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.
This research study is being done to find out if giving zoledronic acid before the cancer spreads to the bone is better or worse than standard treatment. The study will also compare the e...
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...
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...
PubMed Articles
Pharmacokinetics, pharmacodynamics, and safety of zoledronic acid in horses.
Objective-To determine the pharmacokinetics, pharmacodynamics, and safety of zoledronic acid in horses. Animals-8 healthy horses. Procedures-A single dose of zoledronic acid (0.057 mg/kg, IV) was admi...
Clinical data suggest concomitant therapy with bisphosphonates and PTH may blunt the anabolic effect of PTH; rodent models suggest infrequently administered bisphosphonates might interact differently....
To demonstrate the effect of zoledronic acid in proliferation, invasion, and migration of human nasopharyngeal carcinoma cell HNE-1 and explore the potential role of VEGF, MMP-2, and MMP-9 proteins in...
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...
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...
