POWER Point of Care Effect on Satisfaction of Treatment

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00549068
First received: October 24, 2007
Last updated: December 4, 2009
Last verified: December 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by Sanofi:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Sanofi
Procter and Gamble
Investigators
Study Director: Mary Tzortzis Sanofi
  More Information

No publications provided

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

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014