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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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 osteoporosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• Osteoporosis as defined by very low bone mineral density in the hip and spine or low bone mineral density in the hip combined with presence of 1-3 mild or moderate fractures of the vertebrae

Exclusion Criteria:

• Low Vitamin D

• Renal insufficiency

• Previous treatment with certain anti-osteoporotic therapies (except after certain washout periods): calcitonin, bisphosphonates, parathyroid hormone (PTH), sodium fluoride, strontium ranelate,

• Previous treatment with testosterone, anabolic steroids or growth hormone

• Chronic use of systemic corticosteroids (oral or i.v.) within the last year

• History of any cancer or metastases within the last 5 years

• History of brittle bone disease, multiple myeloma, or Paget's disease, or any other metabolic bone disease, except osteoporosis

• Bilateral hip replacements

Other protocol-defined inclusion/exclusion criteria may apply