NCT00100607

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
676

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

1.6 years

First QC Date

January 3, 2005

Last Update Submit

May 7, 2012

Conditions

Osteoporosis

Keywords

osteoporosis/osteopenia, BMD, postmenopausal

Outcome Measures

Primary Outcomes (2)

  • Lumbar spine BMD and total hip BMD after 1 year treatment

  • Safety and tolerability of one year treatment with different doses

Secondary Outcomes (4)

  • 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

Interventions

AAE581DRUG

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMD T Score between -2 to -3.5
  • years old

You may not qualify if:

  • Urolithiasis
  • Bisphosphonates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2005

First Posted

January 4, 2005

Study Start

February 1, 2004

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

May 8, 2012

Record last verified: 2012-05