A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years
- Registration Number
- NCT00909961
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical markers of bone in post-menopausal osteoporotic patients aged between 50-65.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 118
Inclusion Criteria
- Postmenopausal osteoporosis
- Patients who has a low bone mineral density at hip or vertebral
- Patients who has an osteoporotic fracture at hip or vertebra
Exclusion Criteria
- Hypersensitivity either to the active substance or to any of the excipients or to any biphosphonates.
- Known metabolic bone disease excluding osteoporosis.
- Serious systemic disorder treated with drugs interfering with bone metabolism.
- Significant liver or renal failure
- Pathologic fracture in the examined body area or elsewhere.
- Previous anti-osteoporotic treatment within 12 months or less prior to the recruitment.
- Patients with hypocalcaemia
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zoledronic acid Zoledronic acid -
- Primary Outcome Measures
Name Time Method Efficacy - BMD 1 year
- Secondary Outcome Measures
Name Time Method Efficacy - Biochemical markers 6 months Safety - Rate of adverse events and serious adverse events 6 months
Trial Locations
- Locations (2)
Novartis Investigative site
🇹🇷Konya, Turkey
Novartis Investigational site
🇹🇷Istanbul, Turkey