A 2-year extension to study 2203, partially randomized, double-blind, placebo-controlled in the first year and open label in the second year, to assess the safety of the dose of AAE581 selected for phase III development in postmenopausal osteoporosis, and the offset of effect on biomarkers and BMD - 2203E1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002952-33-SK

Enrollment

550

Registered

2005-02-17

Start date

2005-03-17

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis is a metabolic bone disease characterized by low bone mass and micro architectural deterioration of bone tissue, leading to enhanced fragility and a consequent increase in fracture risk.

Interventions

Product Name: AAE581 50 mg coated tablets Product Code: AAE581 Pharmaceutical Form: Coated tablet INN or Proposed INN: balicatib CAS Number: 354813-19-7 Current Sponsor code: AAE581 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Any patient who completed the core study 2203. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: The patients who were non-compliant or who demonstrated a major protocol violation in the core study and who developed any disease mentioned in the exclusion criteria of the core study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To obtain 3-year safety data of AAE581 for phase 3 program. ;Secondary Objective: To assess long-term efficacy of AAE581 on BMD by DXA on lumbar spine, total hip, total body, forearm and the effect on biomarkers over the 24 month extension period and over the entire 36 month period of the combined core and extension studies, and to obtain the offset of action over one year on biomarkers and BMD.;Primary end point(s): To obtain 3-year safety data of AAE581 for phase 3 program.	—

Measure

Time frame

Main Objective: To obtain 3-year safety data of AAE581 for phase 3 program. ;Secondary Objective: To assess long-term efficacy of AAE581 on BMD by DXA on lumbar spine, total hip, total body, forearm and the effect on biomarkers over the 24 month extension period and over the entire 36 month period of the combined core and extension studies, and to obtain the offset of action over one year on biomarkers and BMD.;Primary end point(s): To obtain 3-year safety data of AAE581 for phase 3 program.

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Countries

Austria, Italy, Slovakia, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026