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Risedronate Sodium in Post Menopausal Osteoporosis
This study has been completed.
First Received: March 28, 2007   Last Updated: March 10, 2008   History of Changes
Sponsors and Collaborators: Sanofi-Aventis
Procter and Gamble
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00453492
  Purpose

The primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women.

The secondary objectives are to measure compliance (50 % drug taken), and persistence, [and urinary NTx (N-telopeptides) (optional)].


Condition Intervention Phase
Osteoporosis, Postmenopausal
Drug: risedronate sodium
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Study pn Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Risedronate Sodium (Actonel) in Administered 35mg Once a Week or 5mg Once Daily

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Measurement of subject satisfaction using a questionnaire at 12 and 24 weeks and a tablets counts at 12 and 24 weeks.
  • Optional: the effects of Actonel on bone resorption will be assessed by a change of urinary NTx, after 12 and 24 weeks of treatment as compared to baseline.

Estimated Enrollment: 246
Study Start Date: January 2004
  Eligibility

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

Inclusion Criteria:

  • Five 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 (≥ 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, Actonel.
  • 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 criteria if the subject has been in remission for at least 6 months prior to enrollment.
  • Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453492

Locations
Turkey
Sanofi-aventis
Istanbul, Turkey
Sponsors and Collaborators
Sanofi-Aventis
Procter and Gamble
Investigators
Study Director: Edibe Taylan Sanofi-aventis, Turkey
  More Information

Additional Information:
No publications provided

Study ID Numbers: HMR4003B_4036
Study First Received: March 28, 2007
Last Updated: March 10, 2008
ClinicalTrials.gov Identifier: NCT00453492     History of Changes
Health Authority: Turkey: Ministry of Health

Study placed in the following topic categories:
Calcium, Dietary
Etidronic Acid
Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Calcium Channel Blockers
Osteoporosis
Bone Density Conservation Agents
Bone Diseases, Metabolic
Cardiovascular Agents
Bone Diseases
Risedronic acid
Menopause

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

ClinicalTrials.gov processed this record on September 10, 2009