A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis (ROSPA-CTx)
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ClinicalTrials.gov Identifier: NCT00632216 |
Recruitment Status :
Completed
First Posted : March 10, 2008
Last Update Posted : March 11, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis, Postmenopausal | Drug: Risedronate Sodium | Phase 4 |
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 |

- To determine the satisfaction of subject with Actonel 35 mg [ Time Frame: Once a Week in the treatment of postmenopausal osteoporosis ]
- To measure response rates in CTX with Actonel 35 mg [ Time Frame: Once A Week ]

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Ages Eligible for Study: | 55 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

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
Study Director: | YEU Wang | Sanofi |
Responsible Party: | YEU Wang/Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00632216 |
Other Study ID Numbers: |
RISED_L_01054 |
First Posted: | March 10, 2008 Key Record Dates |
Last Update Posted: | March 11, 2008 |
Last Verified: | March 2008 |
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Risedronic Acid |
Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Bone Density Conservation Agents |