NCT00544180

Brief Summary

To determine the satisfaction of subject with Actonel 35 mg Once a Week in the treatment of post-menopausal osteoporosis. Open, non-controlled, multi-center study.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
Last Updated

September 25, 2009

Status Verified

September 1, 2009

Enrollment Period

1.3 years

First QC Date

October 15, 2007

Last Update Submit

September 24, 2009

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction and compliance

    During all the study

Interventions

RisedronateDRUG

Eligibility Criteria

Age55 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal ambulatory women
  • Established osteoporosis

You may not qualify if:

  • History of cancer: basal cell or squamous cell carcinoma-documented 6-month remission,
  • Diagnosis of hypocalcemia, hyperparathyroidism, hyperthyroidism
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Netanya, Israel

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jean-Marc Chantelot, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 15, 2007

First Posted

October 16, 2007

Study Start

May 1, 2005

Primary Completion

September 1, 2006

Last Updated

September 25, 2009

Record last verified: 2009-09

Locations

IL(1)