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Clinical Trials/NCT00170911
NCT00170911CompletedPhase 2

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

Novartis Pharmaceuticals0 sites160 target enrollmentStarted: March 1, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
160
Primary Endpoint
Change of lumbar spine(L1-L4)BMD at 12 months
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
50 Years to 75 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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