Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With 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
 osteoporosis.
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