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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00170911
First Posted: September 15, 2005
Last Update Posted: November 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00170911


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00170911     History of Changes
Other Study ID Numbers: CAAE581A1201
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: November 2, 2011
Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Osteoporosis
Postmenopausal women
Cathepsin K inhibitor

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