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

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Novartis

Status and phase

Completed
Phase 2

Conditions

Osteoporosis

Treatments

Drug: AAE581

Study type

Interventional

Funder types

Industry

Identifiers

NCT00170911
CAAE581A1201

Details and patient eligibility

About

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.

Sex

Female

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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