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NCT00632216 Clinical Trial

A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis

Osteoporosis, Postmenopausal Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00632216
Other study ID # RISED_L_01054
Secondary ID
Status Completed
Phase Phase 4
First received March 3, 2008
Last updated March 10, 2008
Start date May 2004
Est. completion date May 2006

Study information
Verified date March 2008
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 464
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Risedronate Sodium

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the satisfaction of subject with Actonel 35 mg Once a Week in the treatment of postmenopausal osteoporosis No
Secondary To measure response rates in CTX with Actonel 35 mg Once A Week No
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