Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00100607

Enrollment

676

Registered

2005-01-04

Start date

2004-02-29

Completion date

2005-09-30

Last updated

2012-05-08

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

Conditions

Osteoporosis

Keywords

osteoporosis/osteopenia, BMD, postmenopausal

Brief summary

This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with osteoporosis.

Interventions

DRUGAAE581

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 75 Years

Healthy volunteers

Inclusion criteria

* BMD T Score between -2 to -3.5 * 50-75 years old

Exclusion criteria

* Urolithiasis * Bisphosphonates Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Lumbar spine BMD and total hip BMD after 1 year treatment	—
Safety and tolerability of one year treatment with different doses	—

Secondary

Measure	Time frame
Effect of the different doses on BMD of lumbar spine, femoral neck, total hip, forearm and total body	—
Effect of the different doses on markers for bone formation and bone resorption	—
Structural information on cortical and trabecular bone at different anatomic sites after 6 and 12 months of treatment	—
Histological information on bone biopsy after 12 months of treatment	—

Outcome results

None listed

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