Back to resultsA Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis (ROSPA-CTx)
Primary Purpose
Osteoporosis, Postmenopausal
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Risedronate Sodium
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis, Postmenopausal
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
To determine the satisfaction of subject with Actonel 35 mg
Secondary Outcome Measures
To measure response rates in CTX with Actonel 35 mg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00632216
Brief Title
A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis
Acronym
ROSPA-CTx
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 Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
464 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Risedronate Sodium
Primary Outcome Measure Information:
Title
To determine the satisfaction of subject with Actonel 35 mg
Time Frame
Once a Week in the treatment of postmenopausal osteoporosis
Secondary Outcome Measure Information:
Title
To measure response rates in CTX with Actonel 35 mg
Time Frame
Once A Week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YEU Wang
Organizational Affiliation
Sanofi
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis
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