Status:
COMPLETED
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Male Osteoporosis
Eligibility:
MALE
50-85 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
1199 Patients enrolled
Trial Details
Trial ID
NCT00439647
Start Date
December 1 2006
End Date
October 1 2010
Last Update
April 21 2017
Active Locations (128)
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1
Novartis Investigative Site
Buenos Aires, Argentina
2
Novartis Investigative Site
Córdoba, Argentina
3
Novartis Investigative Site
Mar del Plata, Argentina
4
Novartis Investigative Site
San Miguel de Tucumán, Argentina