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

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

AAE581

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Postmenopausal women, Cathepsin K inhibitor

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)Female

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.

Sites / Locations

Outcomes

Primary Outcome Measures

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

Safety of 12 month treatment

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00170911

First Posted

September 9, 2005

Last Updated

November 1, 2011

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00170911

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

December 2005 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

Osteoporosis, Postmenopausal women, Cathepsin K inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

160 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

AAE581

Primary Outcome Measure Information:

Title

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

Title

Safety of 12 month treatment

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis

Organizational Affiliation

Sponsor GmbH

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

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