Back to resultsA 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
Primary Purpose
Postmenopausal Osteoporosis
Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Osteoporosis, Bone Mineral Density, Biomarkers
Eligibility Criteria
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
Sites / Locations
- Novartis Investigational site
- Novartis Investigative site
- Novartis Investigational site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Zoledronic acid
Arm Description
Outcomes
Primary Outcome Measures
Efficacy - BMD
Secondary Outcome Measures
Efficacy - Biochemical markers
Safety - Rate of adverse events and serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00909961
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 16, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
Osteoporosis, Bone Mineral Density, Biomarkers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zoledronic acid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Primary Outcome Measure Information:
Title
Efficacy - BMD
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Efficacy - Biochemical markers
Time Frame
6 months
Title
Safety - Rate of adverse events and serious adverse events
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigational site
City
Ankara
Country
Turkey
Facility Name
Novartis Investigative site
City
Antalya
Country
Turkey
Facility Name
Novartis Investigational site
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigative site
City
Izmir
Country
Turkey
Facility Name
Novartis Investigative site
City
Kayseri
Country
Turkey
Facility Name
Novartis Investigative site
City
Konya
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
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
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