A one year multicenter, randomized, double-blind, placebocontrolled, parallel group study to evaluate the efficacy and safety of a single intravenous 5 mg dose zoledronic acid for the treatment of osteoporosis in men - ND
- Conditions
- osteoporosisMedDRA version: 9.1Level: LLTClassification code 10031282Term: Osteoporosis
- Registration Number
- EUCTR2006-005893-37-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 124
Male patients between 50 and 85 years of age, inclusive Bone mineral density T-score of less than or equal to -2.5 SD at the total hip or femoral neck AND less than or equal to -1.5 SD at the lumbar spine as confirmed by the central expert reader
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 i.m. or orally once at Visit 1 and have the vitamin D test repeated at Visit 1A to be done after at least 3 weeks have passed . Baseline renal insufficiency calculated creatinine clearance less than 30.0 mL/min at Visit 1 and/or Visit 1A 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 three times the upper limit of normal Serum alkaline phosphatase greater than 1.5 times the upper limit of normal Any disease or deformation of the spine that would preclude the proper acquisition of a lumbar spine DXA L1-L4 e.g. implantable devices, scoliosis, ankylosing spondylitis
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