POWER Point of Care Effect on Satisfaction of Treatment

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

2433 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-11-30

Brief Summary

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To compare the subject satisfaction rating in women treated for postmenopausal osteoporosis with Actonel 35mg Once-a-Week for 24 weeks, and receiving feedback information, after 12 weeks of treatment, based on bone resorption marker results using the NTx Point-Of-Care (POC) device, to similar women treated as per regular clinical practice

Detailed Description

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Conditions

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Osteoporosis, Postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Risedronate Sodium (Actonel)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women diagnosed with postmenopausal osteoporosis using community practice standards
* Women previously non-treated for osteoporosis, OR treated for osteoporosis with biphosphonates (alendronate, etidronate), hormone replacement therapy estrogen, estrogen-related drugs, progesterone, subcutaneous estrogen implant), raloxifene, fluoride, or calcitonin within the past 2 years but discontinued prior to enrolment into the study either due to:lack of effect or intolerance

Exclusion Criteria

* Subjects treated with Actonelr 5 mg daily,
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
* Known/Suspected hypersensitivity to any component of Actonelr 35 mg Once-a-Week
* Known/Suspected hypocalcaemia
* Known/Suspected severe renal impairment (creatinine clearance \< 30ml/min)
* Known/Suspected hyperparathyroidism
* Known/Suspected hyperthyroidism
* Known/Suspected active urinary tract infection
* Known high urine levels of calcium (3 4mg/ml)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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sanofi-aventis

Principal Investigators

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Mary Tzortzis

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

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HMR4003B_4031

Identifier Type: -

Identifier Source: org_study_id