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Satisfaction and Compliance of Risedronate in PMO

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00549965
First received: October 24, 2007
Last updated: October 26, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Osteoporosis, Postmenopausal
Drug: Risedronate Sodium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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. ]

Enrollment: 202
Study Start Date: October 2003
  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549965

Locations
Korea, Republic of
Sanofi-Aventis
Daegu, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Choe Seong Choon Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00549965     History of Changes
Other Study ID Numbers: HMR4003B_4035
Study First Received: October 24, 2007
Last Updated: October 26, 2007
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Risedronic acid
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014