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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170911
• Other study ID #: CAAE581A1201
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: November 1, 2011
• Start date: March 2005

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. primary completion date: December 2005
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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.

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	Change of lumbar spine(L1-L4)BMD at 12 months
Primary	Safety of 12 month treatment
Secondary	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
Secondary	Change of Bone markers(Serum CTX,P1NP, OC, BSAP and urinary NTX, DPyr at 1,3,6,9 and 12 months
Secondary	Plasma concentration of AAE581 and AEE325 at 1,3,6,9 and 12 months