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

Novartis Pharmaceuticals160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Osteoporosis

Interventions

AAE581DRUG

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change of lumbar spine(L1-L4)BMD at 12 months

Safety of 12 month treatment

Secondary Outcomes

Change of BMD of lumbar spine(L1-L4,L2-L4)、total hip, femoral neck, forearm and total body at 3, 6, 9 and 12 months

Change of Bone markers(Serum CTX,P1NP, OC, BSAP and urinary NTX, DPyr at 1,3,6,9 and 12 months

Plasma concentration of AAE581 and AEE325 at 1,3,6,9 and 12 months

Data from ClinicalTrials.gov

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