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Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

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.
ClinicalTrials.gov Identifier: NCT00100607
Recruitment Status : Completed
First Posted : January 4, 2005
Last Update Posted : May 8, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with osteoporosis.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: AAE581 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 676 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
Study Start Date : February 2004
Primary Completion Date : September 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Lumbar spine BMD and total hip BMD after 1 year treatment
  2. Safety and tolerability of one year treatment with different doses

Secondary Outcome Measures :
  1. Effect of the different doses on BMD of lumbar spine, femoral neck, total hip, forearm and total body
  2. Effect of the different doses on markers for bone formation and bone resorption
  3. Structural information on cortical and trabecular bone at different anatomic sites after 6 and 12 months of treatment
  4. Histological information on bone biopsy after 12 months of treatment

Eligibility Criteria

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
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • BMD T Score between -2 to -3.5
  • 50-75 years old

Exclusion Criteria:

  • Urolithiasis
  • Bisphosphonates

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): NCT00100607

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00100607     History of Changes
Other Study ID Numbers: CAAE581A2203
First Posted: January 4, 2005    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
osteoporosis/osteopenia, BMD, postmenopausal

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