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POWER Point of Care Effect on Satisfaction of Treatment

Primary Purpose

Osteoporosis, Postmenopausal

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Risedronate Sodium (Actonel)

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

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

Full Information

NCT ID

NCT00549068

First Posted

October 24, 2007

Last Updated

December 4, 2009

Sponsor

Sanofi

Collaborators

Procter and Gamble

1. Study Identification

Unique Protocol Identification Number

NCT00549068

Brief Title

POWER Point of Care Effect on Satisfaction of 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 Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

February 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

Collaborators

Procter and Gamble

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Postmenopausal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2433 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Risedronate Sodium (Actonel)

Primary Outcome Measure Information:

Title

Secondary Outcome Measure Information:

Title

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Tzortzis

Organizational Affiliation

Sanofi

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

POWER Point of Care Effect on Satisfaction of Treatment

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