NCT00170911

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Last Updated

November 2, 2011

Status Verified

November 1, 2011

Enrollment Period

9 months

First QC Date

September 9, 2005

Last Update Submit

November 1, 2011

Conditions

Osteoporosis

Keywords

OsteoporosisPostmenopausal womenCathepsin K inhibitor

Outcome Measures

Primary Outcomes (2)

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

  • Safety of 12 month treatment

Secondary Outcomes (3)

  • 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

Interventions

AAE581DRUG

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Novartis

    Sponsor GmbH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

March 1, 2005

Primary Completion

December 1, 2005

Last Updated

November 2, 2011

Record last verified: 2011-11