An observational, safety follow-up extension to studies 2203 and 2203E1 to assess the safety of AAE581 in postmenopausal women with osteopenia/osteoporosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002243-25-PL

Enrollment

675

Registered

2007-07-17

Start date

2007-08-28

Completion date

Unknown

Last updated

2015-03-16

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

Conditions

Osteoporosis

Interventions

Pharmaceutical Form: Film-coated tablet INN or Proposed INN: balicatib CAS Number: 354813-19-7 Current Sponsor code: AAE581 Concentration unit: mg milligram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • All patients randomized in the CAAE581A2203 core study • Patients who have signed a written informed consent before any trial procedure is performed 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: • Patients who have taken any anti-osteoporosis therapy since study participation (core or extension E1)

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify if any dose group not otherwise treated with anti-osteoporosis therapy since core study participation shows a signal of continued increase of =20% in the bone marker serum CTX-I beyond 6 months off treatment from baseline (entry into the core study) and versus the placebo group. ;Secondary Objective: 1. To identify if any individual shows continued increase of =40% in the bone marker serum CTX-I beyond 6 months off treatment versus entry into the core study. 2. To identify if any dose group lost BMD at the lumbar spine or total hip more than the placebo group, evaluated by percentage change from baseline (entry into core study) to time of evaluation in the E2 extension study 3. To identify any individuals with a BMD loss of greater than 5%/year at the total hip or 8%/year at the lumbar spine from end of treatment to time of evaluation in the E2 extension study and with a BMD value lower than the baseline value (entry into core study) 4. To evaluate the incidence of AEs since last visit in the core study for patients who did not enter the extension study respectively last visit in the E1 extension study, with a special focus on respiratory, skin, osteoporosis and OA related events, between treatment groups ;Primary end point(s): Biomarker serum CTX-I analysis will be performed by calculating the percentage change form baseline (entry of the core study) to off treatment visit 24 values. Descriptive summary statistics and between treatment group comparisons will be performed included time on treatment and time off treatment as covariates into an analysis of variance model. The original 12 treatments groups will be regrouped in order to create 5 groups: Each AAE581 group will be primarily compared versus placebo. The groups will be as following: • Group1: Placebo • Group2: Placebo/ AAE581 50 mg + 5 mg/ 50 mg + 10mg/ 50 mg + 25 mg/ 50 mg + 50mg/ nothing + 50 mg/ 50mg + 50 mg/ Placebo • Group3: AAE581 5 mg • Group4: AAE581 10 mg	—

Measure

Time frame

Main Objective: To identify if any dose group not otherwise treated with anti-osteoporosis therapy since core study participation shows a signal of continued increase of =20% in the bone marker serum CTX-I beyond 6 months off treatment from baseline (entry into the core study) and versus the placebo group. ;Secondary Objective: 1. To identify if any individual shows continued increase of =40% in the bone marker serum CTX-I beyond 6 months off treatment versus entry into the core study. 2. To identify if any dose group lost BMD at the lumbar spine or total hip more than the placebo group, evaluated by percentage change from baseline (entry into core study) to time of evaluation in the E2 extension study 3. To identify any individuals with a BMD loss of greater than 5%/year at the total hip or 8%/year at the lumbar spine from end of treatment to time of evaluation in the E2 extension study and with a BMD value lower than the baseline value (entry into core study) 4. To evaluate the incidence of AEs since last visit in the core study for patients who did not enter the extension study respectively last visit in the E1 extension study, with a special focus on respiratory, skin, osteoporosis and OA related events, between treatment groups ;Primary end point(s): Biomarker serum CTX-I analysis will be performed by calculating the percentage change form baseline (entry of the core study) to off treatment visit 24 values. Descriptive summary statistics and between treatment group comparisons will be performed included time on treatment and time off treatment as covariates into an analysis of variance model. The original 12 treatments groups will be regrouped in order to create 5 groups: Each AAE581 group will be primarily compared versus placebo. The groups will be as following: • Group1: Placebo • Group2: Placebo/ AAE581 50 mg + 5 mg/ 50 mg + 10mg/ 50 mg + 25 mg/ 50 mg + 50mg/ nothing + 50 mg/ 50mg + 50 mg/ Placebo • Group3: AAE581 5 mg • Group4: AAE581 10 mg

—

Countries

Austria, Czech Republic, France, Poland, Spain

Outcome results

None listed

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