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OpenTrials
Completed

NCT Number: NCT00170911

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

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.

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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

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

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.

Treatment and study plan

AAE581

Drug

Primary outcomes

  1. Change of lumbar spine(L1-L4)BMD at 12 months

  2. Safety of 12 month treatment

Secondary outcomes

  1. 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

  2. Change of Bone markers(Serum CTX,P1NP, OC, BSAP and urinary NTX, DPyr at 1,3,6,9 and 12 months

  3. Plasma concentration of AAE581 and AEE325 at 1,3,6,9 and 12 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2005
Primary completion
2005
First posted
Sep 15, 2005
Registry last updated
Nov 2, 2011

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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