NCT00577421

Brief Summary

A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)

Trial Health

93
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2003

Typical duration for phase_3

Geographic Reach
5 countries

5 active sites

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

June 1, 2003

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
Last Updated

September 28, 2011

Status Verified

September 1, 2011

First QC Date

December 19, 2007

Last Update Submit

September 27, 2011

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • To assess the safety and tolerability profile of 5 mg daily oral risedronate therapy administered for 2 years in patients with post-menopausal osteoporosis, who had received risedronate for 2 or 7 years and then had a risedronate-free year.

    2 years

Study Arms (1)

1

EXPERIMENTAL

5 mg/day risedronate

Drug: risedronate

Interventions

risedronateDRUG

5 mg tablet of risedronate once a day for 2 years

1

Eligibility Criteria

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

You may qualify if:

  • have satisfactorily completed Clinical Study RVE2001079 (Year 8 extension study)

You may not qualify if:

  • Can not use any bone modifying substances except risedronate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Concord, Australia

Location

Research Facility

Siena, Italy

Location

Research Facility

Warsaw, Poland

Location

Research Facility

Barcelona, Spain

Location

Research Facility

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dietrich H Wenderoth, MD

    Procter and Gamble

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 20, 2007

Study Start

June 1, 2003

Study Completion

January 1, 2006

Last Updated

September 28, 2011

Record last verified: 2011-09

Locations

SE(1)ES(1)IT(1)PL(1)AU(1)