Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

Osteoporosis Clinical Trial

Official title:

Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00100607
• Other study ID #: CAAE581A2203
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2005
• Last updated: May 7, 2012
• Start date: February 2004
• Est. completion date: September 2005

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaAustria: Federal Ministry for Health and WomenFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Czech Republic: State Institute for Drug ControlItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthSpain: Spanish Agency of MedicinesSlovakia: State Institute for Drug ControlRussia: Pharmacological Committee, Ministry of HealthPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 676
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• AAE581

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar spine BMD and total hip BMD after 1 year treatment
Primary	Safety and tolerability of one year treatment with different doses
Secondary	Effect of the different doses on BMD of lumbar spine, femoral neck, total hip, forearm and total body
Secondary	Effect of the different doses on markers for bone formation and bone resorption
Secondary	Structural information on cortical and trabecular bone at different anatomic sites after 6 and 12 months of treatment
Secondary	Histological information on bone biopsy after 12 months of treatment