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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

464 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2006-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis, Postmenopausal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Risedronate Sodium

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No