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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00170911

Enrollment

160

Registered

2005-09-15

Start date

2005-03-31

Completion date

Unknown

Last updated

2011-11-02

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

Conditions

Osteoporosis

Keywords

Osteoporosis, Postmenopausal women, Cathepsin K inhibitor

Brief summary

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.

Interventions

DRUGAAE581

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 75 Years

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/

Design outcomes

Primary

Measure	Time frame
Change of lumbar spine(L1-L4)BMD at 12 months	—
Safety of 12 month treatment	—

Secondary

Measure	Time frame
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	—
Change of Bone markers(Serum CTX,P1NP, OC, BSAP and urinary NTX, DPyr at 1,3,6,9 and 12 months	—
Plasma concentration of AAE581 and AEE325 at 1,3,6,9 and 12 months	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026