Satisfaction and Compliance of Risedronate in PMO

October 26, 2007 updated by: Sanofi

A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Phase IV Study in Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Actonel(Rosedronate) is Administered 35mg Once a Week or 5mg

Compare subject satisfaction of once a week dosing of 35 mg Risedronate to once daily dosing of 5 mg Risedronate in postmenopausal osteoporotic women. Secondary objectives are to measure compliance (50 % drug taken), and persistence.

Study Overview

Status

Completed

Conditions

Osteoporosis, Postmenopausal

Intervention / Treatment

Drug: Risedronate Sodium

Study Type

Interventional

Enrollment (Actual)

202

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- - Daegu, Korea, Republic of
    - Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Five (5) years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria.
Subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (> than or = to 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. During the study, these drugs are not permitted other than the study medication, Risedronate.
Other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication they may be given at the discretion of the Investigator.

Exclusion Criteria:

Had a history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion if the subject has been in remission for at least 6 months prior to enrollment.
Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.
History of alcohol and/or drug abuse.
Subjects will be excluded for active gastrointestinal disease that may interfere with absorption or with ability to swallow an oral medication.
Subjects will also be excluded for serious concurrent illness that would interfere with their ability to participate in the trial.
Excluded medications: bisphosphonates, calcitonin or fluoride or hormone replacement therapy within the last 6 months.
Known hypersensitivity to bisphosphonates and/or excipients.
Abnormal laboratory parameters, which are clinically relevant according to the Investigator (including renal insufficiency; creatinine clearance < 30 mL/min)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of subject satisfaction of once a week 35 mg Risedronate and once daily 5 mg Risedronate. Time Frame: A subject-administered questionnaire at 12 and 24 weeks will assess satisfaction.	A subject-administered questionnaire at 12 and 24 weeks will assess satisfaction.

Secondary Outcome Measures

Outcome Measure	Time Frame
The subjects' compliance and persistence on treatment. Compliance as defined by more than 50% of the drug taken (by tablet count) during each Risedronate treatment period. Time Frame: Persistence at week 12 and 24 will be defined as continuing Risedronate treatment.	Persistence at week 12 and 24 will be defined as continuing Risedronate treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

Study Director: Choe Seong Choon, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Registration Dates

First Submitted

October 24, 2007

First Submitted That Met QC Criteria