Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

Novartis Pharmaceuticals676 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

676

Conditions

Osteoporosis

Interventions

AAE581DRUG

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Lumbar spine BMD and total hip BMD after 1 year treatment

Safety and tolerability of one year treatment with different doses

Secondary Outcomes

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

Data from ClinicalTrials.gov

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