Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

Phase 2

Completed

• Conditions: Osteoporosis

• Registration Number: NCT00100607
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-01-03
• Study First Submitted QC: 2005-01-03
• Study First Posted: 2005-01-04
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-07
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 676

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lumbar spine BMD and total hip BMD after 1 year treatment
Safety and tolerability of one year treatment with different doses

Secondary Outcome Measures

Name	Time	Method
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