Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00100607
First received: January 3, 2005
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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
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: 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)
  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100607

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov 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:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 16, 2014