POWER Point of Care Effect on Satisfaction of Treatment

NCT00549068 | Completed Phase 4

• 1 other identifier: HMR4003B_4031
• Study Type: interventional
• Target: 2,433
• Locations: 0 countries
• Sites: N/A

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

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (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 Outcomes (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

Interventions

Risedronate Sodium (Actonel) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Procter and Gamble: collaborator

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mary Tzortzis

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 25, 2007
• Study Start: February 1, 2003
• Study Completion: November 1, 2004
• Last Updated: December 7, 2009

Record last verified: 2009-12