Back to resultsSafety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AAE581
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis/osteopenia, BMD, postmenopausal
Eligibility Criteria
Inclusion Criteria: BMD T Score between -2 to -3.5 50-75 years old Exclusion Criteria: Urolithiasis Bisphosphonates Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
Lumbar spine BMD and total hip BMD after 1 year treatment
Safety and tolerability of one year treatment with different doses
Secondary Outcome Measures
Effect of the different doses on BMD of lumbar spine, femoral neck, total hip, forearm and total body
Effect of the different doses on markers for bone formation and bone resorption
Structural information on cortical and trabecular bone at different anatomic sites after 6 and 12 months of treatment
Histological information on bone biopsy after 12 months of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00100607
Brief Title
Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
Official Title
Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (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 test the safety and efficacy of AAE581 in increasing Lumbar Spine bone mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with osteoporosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
osteoporosis/osteopenia, BMD, postmenopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
676 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AAE581
Primary Outcome Measure Information:
Title
Lumbar spine BMD and total hip BMD after 1 year treatment
Title
Safety and tolerability of one year treatment with different doses
Secondary Outcome Measure Information:
Title
Effect of the different doses on BMD of lumbar spine, femoral neck, total hip, forearm and total body
Title
Effect of the different doses on markers for bone formation and bone resorption
Title
Structural information on cortical and trabecular bone at different anatomic sites after 6 and 12 months of treatment
Title
Histological information on bone biopsy after 12 months of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMD T Score between -2 to -3.5
50-75 years old
Exclusion Criteria:
Urolithiasis
Bisphosphonates
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
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
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