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-IS
- 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 and/or belonging to the subset of at least 100 patients at the selected sites. For details regarding the imaging assessments of the subset of patients at the selected sites, please se Section 7.4.3
• 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.
As per Amendment 2, this inclusion criterion is not applicable in Finland.
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 mild to moderate vertebral fracture 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. In Denmark, patients with a BMD T-score below -3 cannot be included if they have any moderate vertebral fractures OR if they have more than 1 moderate vertebral fracture despite the T-score level.
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 < 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.
• Baseline renal insufficiency (calculated creatinine clearance < 30.0 mL/min)
at Visit 1 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 calculated
creatinine clearance equal to or greater than 30.0 mL/min and < 60.0
mL/min or serum creatinine greater than the upper limit of normal at Visit 1 must
be verified at a second visit (Visit 1A). The average creatinine clearance of the two tests must be equal to or > 30.0 mL/min and the result of the creatinine retest must be below the upper limit of normal. (Patients with calculated creatinine
clearance > 60.0 mL/min and serum creatinine equal to or less than 2.0 mg/dL do not require re-test) In the UK patients with a urine dipstick result greater than trace protein without evidence of contamination or bacteriuria cannot be included.
• Patients who require re-test of creatinine clearance at Visit 1A will be excluded if
there is an increase in serum creatinine > 0.5 mg/dL between Visit 1
and Visit 1A.
• Hypercalcemia, defined as serum calcium > or equal to 2.75 mmol/L
(11.0 mg/dL) at Visit 1 or Visit 1A.
• Hypocalcemia, defined as serum calcium < or equal to 2.0 mmol/L (8.0
mg/dL) at Visit 1 or Visit 1A.
• AST or ALT > 3 times the upper limit of normal
• Serum alkaline phosphatase > 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 > or equal to 4 weeks but < 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 > 8 weeks but < 48 weeks)
- 6 months (if used for > 2 weeks but < 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 randomization.
• Cancer exclusions:
- Patients with evidence of any cancer or
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