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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AAE581

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis

Role: STUDY_CHAIR

Sponsor GmbH

Other Identifiers

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CAAE581A1201

Identifier Type: -

Identifier Source: org_study_id