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OpenTrials
Completed

NCT Number: NCT00100607

Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AAE581

Drug

Primary outcomes

  1. Lumbar spine BMD and total hip BMD after 1 year treatment

  2. Safety and tolerability of one year treatment with different doses

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 4, 2005
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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