Satisfaction and Compliance of Risedronate in PMO

NCT00549965 | Completed Phase 4

• 1 other identifier: HMR4003B_4035
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

• Measurement of subject satisfaction of once a week 35 mg Risedronate and once daily 5 mg Risedronate.

  A subject-administered questionnaire at 12 and 24 weeks will assess satisfaction.

Secondary Outcomes (1)

• 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.

  Persistence at week 12 and 24 will be defined as continuing Risedronate treatment.

Interventions

Risedronate Sodium DRUG

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Daegu, South Korea

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Choe Seong Choon

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 26, 2007
• Study Start: October 1, 2003
• Last Updated: October 30, 2007

Record last verified: 2007-10

Locations

KR (1)