Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.

Novartis

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Drug: AAE581

Study type: Interventional

Funder types: Industry

Identifiers

NCT00170911

CAAE581A1201

Details and patient eligibility

About

AAE581 is a specific inhibitor of the cysteine protease cathepsin K. This trial is designed to provide detailed information about the effects( efficacy and safety) of AAE581 on Bone Mineral Density.

Sex: Female

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low spine Bone Mineral Density
• 0 to 1 prevalent fracture in non lumber spine

Exclusion criteria

• History or presence of any bone disease other than osteopenia /osteoporosis
• Previous treatment with other anti-osteoporosis agent(Wash out required)
• Evidence of vitamin D deficiency

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind