A two year multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the fracture efficacy and safety of intravenous zoledronic acid 5 mg annually for the treatment of osteoporosis in men - NA
- Conditions
- Treatment of osteoporosis in men
- Registration Number
- EUCTR2004-004131-57-SE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1072
• Male patients between 50 and 85 years of age, inclusive
• At least three readable L1-L4 vertebra, confirmed by the centralized expert readers prior to randomization:only applicable for patients qualifying via BMD at the lumbar spine.
• Bone mineral density T-score of less than or equal to -2.5 SD at the total hip or femoral neck OR less than or equal to -2.5 SD at the lumbar spine as confirmed by the central expert reader.
OR
• Bone mineral density T-score of less than or equal to -1.5 SD at the total hip or femoral neck as confirmed by the central expert reader, AND at least 1 up to a maximum of 3 prevalent vertebral fractures of mild or moderate grade as defined by the modified Genant method for males and confirmed by the central expert reader.
Important: The BMD T-score must be confirmed by the central expert reader prior to randomization. Additionally, vertebral x-rays (lateral thoracic and lumbar views) will be performed and must be submitted to the central imaging laboratory for confirmation of prevalent vertebral fractures prior to randomization.
Please note: Patients with more than 3 or any severe vertebral fracture or patients with acute painful osteoporotic fractures requiring treatment with any of the prohibited medications can not be included in the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Patients with 25-(OH) Vitamin D levels less than 15 ng/mL at Visit 1. If the vitamin
D level is < 15 ng/ml the patient should receive a loading dose of 75,000-100,000
IU of vitamin D IM or orally once at visit 1 and have the vitamin D test repeated at
visit 1A. This repeat test for vitamin D should be done after at least 3 weeks have
passed since the loading dose was given.
• A Baseline renal insufficiency (calculated creatinine clearance (cal CrCl)less than 30.0 mL/min at Visit 1 (V1) and/or Visit 1A or urine dipstick greater than or equal to 2+ protein without evidence of contamination or bacteriuria (may be repeated one time at least a week apart if there is suspicion of contamination). Patients with cal CrCl equal to or greater than 30.0 mL/min and less than 60.0 mL/min or serum (S) Cr greater than 2.0 mg/mL at V1 must be verified at a second visit (V1A). The average cal CrCl of the two tests must be equal to or higher than 30.0 mL/min and the result of the Cr retest must be below or equal to 2.0 mg/dL. (Patients with cal CrCl greater than 60.0 mL/min and S CrCl within normal limits at Visit 1 do not require re-test).
• Patients who require re-test of CrCl at Visit 1A will be excluded if there is an increase in SCr greater than 0.5 mg/dL between Visit 1 and Visit 1A. SCr may be repeated once and the investigator may discuss with the Novartis Clinical Research Physician whether to consider the patient’s entry into the trial based on the repeated SCr result and the patient’s overall renal status.
• Hypercalcemia, defined as serum calcium greater than or equal to 2.75 mmol/L
(11.0 mg/dL) at Visit 1 or Visit 1A.
• Hypocalcemia, defined as serum calcium less than or equal to 2.0 mmol/L (8.0
mg/dL) at Visit 1 or Visit 1A.
• AST or ALT greater than 3 times the upper limit of normal
• Serum alkaline phosphatase greater than 1.5 times the upper limit of normal
• Previous use of calcitonin except according to the following washout schedule,
measured from randomization:
- 6 months (if used for 12 weeks or longer)
- 3 months (if used for greater than or equal to 4 weeks but less or equal to 12
weeks)
• Hypersensitivity to bisphosphonates
• Prior treatment with i.v. bisphosphonates within the last 2 years prior to
randomization
• Use of oral bisphosphonates except according to the following washout schedule,
measured from the date of randomization:
- 2 years (if used for 48 weeks or longer)
- 1 year (if used for greater than 8 weeks but less than 48 weeks)
- 6 months (if used for greater than 2 weeks but less than or equal to 8 weeks)
• Any prior use of PTH for more than 1 week; if used for less than or equal to 1
week, the washout period for PTH is 3 months prior to randomization.
• Any prior use of strontium ranelate or sodium fluoride
• Use of testosterone therapy within one year prior to randomization.
• Chronic use of systemic corticosteroids (oral or i.v.) within the last year:
NOTE: Use of corticosteroids in forms such as topical creams, nasal or inhaled
formulations or those injected locally (intra-articularly) are NOT exclusionary.
• Prior exposure to anabolic steroids or growth hormone within 6 months prior to
randomization
• Treatment with any investigational drug(s) and/or devices within 30 days prior to
randomization.
• History of iritis or uveitis, except when secondary to trauma, and must have
resolved for more than 2 years prior to r
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method