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

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00632216

First received: March 3, 2008

Last updated: March 10, 2008

Last verified: March 2008

History of Changes

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To measure response rates in CTX with Actonel 35 mg [ Time Frame: Once A Week ] [ Designated as safety issue: No ]


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

Eligibility


Ages Eligible for Study:	55 Years to 70 Years (Adult, Senior)
Genders 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

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: 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
Study First Received:	March 3, 2008
Last Updated:	March 10, 2008
Health Authority:	Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on September 29, 2016

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