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POWER Point of Care Effect on Satisfaction of Treatment

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00549068
Collaborator
Procter and Gamble (Industry)
2,433
Enrollment
21
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Risedronate Sodium (Actonel)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
2433 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Feb 1, 2003
Actual Study Completion Date :
Nov 1, 2004

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Sanofi
  • Procter and Gamble

Investigators

  • Study Director: Mary Tzortzis, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00549068
Other Study ID Numbers:
  • HMR4003B_4031
First Posted:
Oct 25, 2007
Last Update Posted:
Dec 7, 2009
Last Verified:
Dec 1, 2009
Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Risedronic Acid

Study Results

No Results Posted as of Dec 7, 2009