Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

Novartis

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Drug: AAE581

Study type: Interventional

Funder types: Industry

Identifiers

NCT00100607

CAAE581A2203

Details and patient eligibility

About

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.

Enrollment: 676 patients

Sex: Female

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind