osteoporosis MedDRA version: 9.1 Level: LLT Classification code 10031282 Term: Osteoporosis
Conditions
Interventions
Product Name: zoledronic acid
Product Code: CZOL446 M
Pharmaceutical Form: Solution for infusion
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical f
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are to demonstrate the superiority of treatment with zoledronic acid Calcium and Vitamin D relative to placebo Calcium and Vitamin D regarding the percent change of BMD at lumbar spine and/or total hip at Month 12 relative to baseline as measured by DXA.;Secondary Objective: The secondary objectives include the evaluation of the following parameters in male osteoporotic patients treated with zoledronic acid Calcium and Vitamin D compared to those treated with placebo Calcium and Vitamin D To demonstrate the superiority of treatment with zoledronic acid Calcium and Vitamin D relative to placebo Calcium and Vitamin D regarding the percent change of BMD at lumbar spine and/or total hip at Month 6 and relative to baseline as measured by DXA. To demonstrate the superiority of treatment with zoledronic acid Calcium and Vitamin D relative to placebo Calcium and Vitamin D regarding the percent change of BMD at femoral neck at Month 6 and Month 12 relative to baseline as measured by DXA. To assess changes in biochemical markers of bone resorption and bone formation at Month 3, 6 and 12 relative to baseline in patients treated with zoledronic acid Calcium and Vitamin D pls see protocol ;Primary end point(s): The primary objectives are to demonstrate the superiority of treatment with zoledronic acid Calcium and Vitamin D relative to placebo Calcium and Vitamin D regarding the percent change of BMD at lumbar spine and/or total hip at Month 12 relative to baseline as measured by DXA. | — |
Countries
Italy
Outcome results
None listed