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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
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632216

Sponsors and Collaborators
Sanofi
Investigators
Study Director: YEU Wang Sanofi
  More Information

No publications provided

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
Risedronic acid
Etidronic Acid
Bone Density Conservation Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013