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A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis (ROSPA-CTx)

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ClinicalTrials.gov Identifier: NCT00632216
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : March 11, 2008
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:
The study in the labeled and real conditions of prescription of Actonel will investigate the satisfaction of patients with its new formulation: 35 mg Once A Week. The study will also measure response rates in CTX (the C-telopeptide of type I collagen) at baseline and after 12 weeks of treatment with risedronate 35 mg Once A Week.

Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Drug: Risedronate Sodium Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 464 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter and Prospective Study to Determine the Satisfaction With Actonel (Risedronate Sodium) 35mg Once a Week Using Biochemical Markers of Bone as a Control, in Postmenopausal Women With Osteoporosis
Study Start Date : May 2004
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To determine the satisfaction of subject with Actonel 35 mg [ Time Frame: Once a Week in the treatment of postmenopausal osteoporosis ]

Secondary Outcome Measures :
  1. To measure response rates in CTX with Actonel 35 mg [ Time Frame: Once A Week ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal outpatients women > 55 and < 70 years who have a clinical presentation appropriate for treatment of established osteoporosis based on the investigator's clinical judgment (a T-score for BMD (DEXA) of lumbar spine or femoral neck less than or equal to - 2.5 from an assessment performed at screening or within 12 months prior to the screening visit or evidence of previous vertebral fracture).

Exclusion Criteria:

  • History of Cancer: Basal Cell or Squamous Cell carcinoma-documented 6-month remission.
  • Diagnosis of hypocalcemia, hyperparathyroidism, 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632216


Sponsors and Collaborators
Sanofi
Investigators
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Study Director: YEU Wang Sanofi
More Information
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Responsible Party: YEU Wang/Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00632216     History of Changes
Other Study ID Numbers: RISED_L_01054
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: March 11, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronic Acid
 Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents