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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	55 Years to 70 Years (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Sanofi

Investigators

Study Director:	YEU Wang	Sanofi

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Last Update Posted:	March 11, 2008
Last Verified:	March 2008

Additional relevant MeSH terms:

Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Risedronate Sodium	Etidronic Acid; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Bone Density Conservation Agents; Physiological Effects of Drugs