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Trial information
A Study of Boniva (Ibandronate) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia
Status: Completed
Protocol number: ML18056
Sponsor: Roche Laboratories Inc.
Company division: Pharmaceutical
Official Scientific Title: A prospective, open-label, two-part study of treatment satisfaction with monthly oral Boniva in women with post-menopausal osteoporosis transitioned from weekly alendronate or risendronate
Brief summary: This study will investigate patient satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Target sample size is
1776.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandronate[Bonviva/Boniva]
Primary outcome: 1. Patient satisfaction; number and proportion of patients who show improvement from baseline satisfaction score after 6 months of Bonviva
Key secondary outcomes: 1. Evaluation of sub-groups (no. and %) with respect to willingness to enter part B, improved satisfaction, dosing schedule preference, compliance, receiving a reminder, GI symptoms, etc
Inclusion criteria: - women receiving once-weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis for >=3 months.
Exclusion criteria: - inability to stand or sit upright for >=60 minutes;
- hypersensitivity to bisphosphonates;
- inability to swallow a tablet whole;
- malignant disease diagnosed within previous 10 years (except resected basal cell cancer).
Gender: Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/30/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:United States - Birmingham, AL
- Huntsville, AL
- Mobile, AL
- Chandler, AZ
- Mesa, AZ
- Paradise Valley, AZ
- Phoenix, AZ
- Tempe, AZ
- Tucson , AZ
- Jonesboro, AR
- Little Rock, AR
- Pine Bluff, AR
- Rogers, AR
- Searcy, AR
- Anaheim, CA
- Beverly Hills, CA
- Laguna Hills, CA
- Mission Viejo, CA
- Palm Desert, CA
- Palo Alto, CA
- Sacramento, CA
- San Diego , CA
- Vista, CA
- Westlake Village, CA
- Colorado Springs, CO
- Avon, CT
- Cromwell, CT
- Hamden, CT
- New London, CT
- Waterbury, CT
- Wilmington, DE
- Aventura, FL
- Clearwater, FL
- Deland, FL
- Fort Myers, FL
- Gainesville, FL
- Longwood, FL
- Melbourne, FL
- Miami, FL
- Ocala, FL
- Palm Bay, FL
- Palm Harbor, FL
- Port Orange, FL
- Sarasota , FL
- West Palm Beach, FL
- Atlanta, GA
- Augusta, GA
- Decatur, GA
- Rome, GA
- Boise, ID
- Coeur D'Alene, ID
- Champaign, IL
- Creve Coeur, IL
- Peoria, IL
- Evansville, IN
- Arkansas City, KS
- Newton, KS
- Wichita, KS
- Natchitoches, LA
- New Orleans, LA
- Baltimore, MD
- Chelsea, MI
- Detroit, MI
- Chaska, MN
- Jefferson City, MO
- Kansas City, MO
- St Louis, MO
- Billings, MT
- Omaha, NE
- Middletown, NJ
- New Brunswick, NJ
- Passaic, NJ
- Princeton , NJ
- Brooklyn, NY
- East Syracuse, NY
- New York, NY
- Olean, NY
- Rochester, NY
- Durham, NC
- Fayetteville, NC
- Morehead City, NC
- Morganton, NC
- Raleigh, NC
- Salisbury, NC
- Wilmington, NC
- Winston-Salem, NC
- Fargo, ND
- Grand Forks, ND
- Beachwood, OH
- Canfield, OH
- Cincinnati, OH
- Columbus, OH
- Oklahoma City, OK
- Tulsa , OK
- Medford, OR
- Portland, OR
- Bala Cynwyd, PA
- Langhorne, PA
- Philadelphia, PA
- West Reading, PA
- Charleston, SC
- Mount Pleasant, SC
- Spartanburg, SC
- Bristol, TN
- Memphis , TN
- Murfreesboro, TN
- Nashville, TN
- Sevierville, TN
- Carrollton, TX
- Corpus Christi, TX
- Dallas, TX
- Denton, TX
- San Antonio, TX
- Wichita Falls, TX
- Norfolk , VA
- Richmond, VA
- Renton, WA
- Seattle, WA
- Spokane , WA
- Tacoma, WA
- Madison, WI
- Milwaukee, WI
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