Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: January 3, 2005
Last updated: May 7, 2012
Last verified: May 2012
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 Intervention Phase
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: Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

Resource links provided by NLM:

Further study details as provided by Novartis:

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

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

Enrollment: 676
Study Start Date: February 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00100607

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

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00100607     History of Changes
Other Study ID Numbers: CAAE581A2203 
Study First Received: January 3, 2005
Last Updated: May 7, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Austria: Federal Ministry for Health and Women
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Spain: Spanish Agency of Medicines
Slovakia: State Institute for Drug Control
Russia: Pharmacological Committee, Ministry of Health
Poland: Ministry of Health

Keywords provided by Novartis:
osteoporosis/osteopenia, BMD, postmenopausal

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases processed this record on December 08, 2016