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POWER Point of Care Effect on Satisfaction of Treatment
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Study NCT00549068   Information provided by Sanofi-Aventis
First Received: October 24, 2007   Last Updated: April 22, 2008   History of Changes

October 24, 2007
April 22, 2008
February 2003
 
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
Same as current
Complete list of historical versions of study NCT00549068 on ClinicalTrials.gov Archive Site
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
Same as current
 
POWER Point of Care Effect on Satisfaction of Treatment
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

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

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Osteoporosis, Postmenopausal
Drug: Risedronate Sodium (Actonel)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
2433
November 2004
 

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.

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00549068
Study Director, sanofi-aventis
HMR4003B_4031
Sanofi-Aventis
Procter and Gamble
Study Director: Mary Tzortzis Sanofi-Aventis
Sanofi-Aventis
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP