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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00170911
First received: September 9, 2005
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoporosis
 Drug: AAE581
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by Novartis:

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

Estimated Enrollment: 160
Study Start Date: March 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Female
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170911

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: Novartis Sponsor GmbH
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00170911     History of Changes
Other Study ID Numbers: CAAE581A1201
Study First Received: September 9, 2005
Last Updated: November 1, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Osteoporosis
Postmenopausal women
Cathepsin K inhibitor

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Osteoporosis
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 21, 2013