POWER Point of Care Effect on Satisfaction of Treatment

Osteoporosis, Postmenopausal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549068
• Other study ID #: HMR4003B_4031
• Status: Completed
• Phase: Phase 4
• First received: October 24, 2007
• Last updated: December 4, 2009
• Start date: February 2003
• Est. completion date: November 2004

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2433
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis, Postmenopausal

Intervention

Drug:
• Risedronate Sodium (Actonel)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Procter and Gamble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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