POWER Point of Care Effect on Satisfaction of Treatment - Full Text View

Sponsor:	Sanofi-Aventis
Collaborator:	Procter and Gamble
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00549068

Purpose

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

Condition	Intervention	Phase
Osteoporosis, Postmenopausal	Drug: Risedronate Sodium (Actonel)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Impact of NTx Point of Care (POC) Device on Patient Satisfication With Actonel 35mg Once a Seek Treatment a Multicenter Prospective Open Label Randomized Controlled Community Practice-based Study

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Risedronic acid Risedronate sodium

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Compare subject satisfaction rating in women treated for postmenopausal osteoporosis with Actonel® 35 mg Once-a-Week for 24 weeks, and receiving feedback information after 12 weeks of treatment to similar women monitored as per regular clinical practice

Secondary Outcome Measures:

Compare subject satisfaction with Actonel® 35 mg Once-a-Week in subject subgroups: previously treated with biphosphonates, HRT, raloxifene, fluoride, or calcitonin within past 2 years vs. those previously non treated

Enrollment:	2433
Study Start Date:	February 2003
Study Completion Date:	November 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549068

Sponsors and Collaborators

Sanofi-Aventis

Procter and Gamble

Investigators

Study Director:

Mary Tzortzis

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Study Director )
Study ID Numbers:	HMR4003B_4031
Study First Received:	October 24, 2007
Last Updated:	December 4, 2009
ClinicalTrials.gov Identifier:	NCT00549068 History of Changes
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Osteoporosis
Calcium Channel Blockers
Bone Diseases, Metabolic
Bone Density Conservation Agents
Cardiovascular Agents

Bone Diseases
Pharmacologic Actions
Membrane Transport Modulators
Musculoskeletal Diseases
Therapeutic Uses
Osteoporosis, Postmenopausal
Risedronic acid

ClinicalTrials.gov processed this record on February 08, 2010