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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00632216

First Posted: March 10, 2008

Last Update Posted: March 11, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Sanofi

Purpose

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	Intervention	Phase
Osteoporosis, Postmenopausal	Drug: Risedronate Sodium	Phase 4


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Risedronate sodium

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

To determine the satisfaction of subject with Actonel 35 mg [ Time Frame: Once a Week in the treatment of postmenopausal osteoporosis ]

Secondary Outcome Measures:

To measure response rates in CTX with Actonel 35 mg [ Time Frame: Once A Week ]


Enrollment:	464
Study Start Date:	May 2004
Study Completion Date:	May 2006

Eligibility

Information from the National Library of Medicine

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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

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


Study Director:	YEU Wang	Sanofi

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 Submitted:	March 3, 2008
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 Risedronate Sodium	Etidronic Acid Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Bone Density Conservation Agents Physiological Effects of Drugs

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