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
A One Year, Local, Open Label, Multicentre Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on BMD and Biochemical Markers of Bone in PMO Pts Between the Ages of 50 and 65 Years
1 other identifier
interventional
118
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2009
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
May 29, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2011
CompletedMarch 21, 2017
March 1, 2017
2.1 years
May 28, 2009
March 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy - BMD
1 year
Secondary Outcomes (2)
Efficacy - Biochemical markers
6 months
Safety - Rate of adverse events and serious adverse events
6 months
Study Arms (1)
Zoledronic acid
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Postmenopausal osteoporosis
- Patients who has a low bone mineral density at hip or vertebral
- Patients who has an osteoporotic fracture at hip or vertebra
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Novartis Investigational site
Ankara, Turkey (Türkiye)
Novartis Investigative site
Antalya, Turkey (Türkiye)
Novartis Investigational site
Istanbul, Turkey (Türkiye)
Novartis Investigative site
Izmir, Turkey (Türkiye)
Novartis Investigative site
Kayseri, Turkey (Türkiye)
Novartis Investigative site
Konya, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2009
First Posted
May 29, 2009
Study Start
November 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 16, 2011
Last Updated
March 21, 2017
Record last verified: 2017-03