Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
50-65 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2011
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00909961
Start Date
November 1 2009
End Date
December 16 2011
Last Update
March 21 2017
Active Locations (6)
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1
Novartis Investigational site
Ankara, Turkey (Türkiye)
2
Novartis Investigative site
Antalya, Turkey (Türkiye)
3
Novartis Investigational site
Istanbul, Turkey (Türkiye)
4
Novartis Investigative site
Izmir, Turkey (Türkiye)