|
|
 |
|
 |
|
Trial information
PRIOR Study - A Study of Boniva (Ibandronate) in Postmenopausal Women With Osteoporosis or Osteopenia
Status: Completed
Protocol number: ML18058
Sponsor: Roche Laboratories Inc.
Company division: Pharmaceutical
Official Scientific Title: An open-label study of level of treatment adherence to monthly oral or every 3-month intravenous Bonviva in women with post-menopausal osteoporosis who are intolerant to daily or weekly alendronate or risendronate therapy
Brief summary: The purpose of this study is to evaluate treatment adherence to different regimens of Bonviva in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Target sample size is 515.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandronate[Bonviva/Boniva]
Primary outcome: 1. Proportion of patients who have >=75% adherence using either monthly oral Bonviva or quarterly IV Bonviva
Key secondary outcomes: 1. Severity and frequency of GI events, and proportion of patients who have a change in pattern of GI events, at screening and months 3 and 10; Safety: adverse events, laboratory tests
Inclusion criteria: - women with postmenopausal osteoporosis or osteopenia;
- discontinuation of daily and /or weekly alendronate or risedronate therapy because of GI intolerance (eg, heartburn, acid reflux, stomach upset).
Exclusion criteria: - inability to stand or sit upright for 60 minutes;
- inability to swallow a tablet whole;
- hypersensitivity to any component of Boniva;
- malignant disease diagnosed within previous 10 years (except resected basal cell cancer);
- contraindications for calcium or vitamin D therapy;
- patients who do not fulfill a minimum 3 months wash-out therapy from any previous bisphosphonate therapy.
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: 9/29/2008
Link to trial result
This trial was conducted at the following locations:United States - Montgomery, AL
- Lake Havasu City, AZ
- Paradise Valley, AZ
- Pine Bluff, AR
- San Diego , CA
- Santa Monica, CA
- Vista, CA
- Beverly Hills, FL
- Fort Myers, FL
- Gainesville, FL
- Miami, FL
- Ocala, FL
- Palm Harbor, FL
- West Palm Beach, FL
- Augusta, GA
- Coeur D'Alene, ID
- Champaign, IL
- Natchitoches, LA
- South Portland, ME
- Detroit, MI
- Kansas City, MO
- St Louis, MO
- Billings, MT
- Broken Bow, NE
- Scottsbluff, NE
- Las Vegas, NV
- Albuquerque, NM
- New York, NY
- West Haverstraw, NY
- Charlotte, NC
- Durham, NC
- Salisbury, NC
- Winston-Salem, NC
- Bismarck, ND
- Fargo, ND
- Canfield, OH
- Columbus, OH
- Mayfield, OH
- Oklahoma City, OK
- West Reading, PA
- Loris, SC
- Mount Pleasant, SC
- Sioux Falls, SD
- Watertown, SD
- Bristol, TN
- Denton, TX
- San Antonio, TX
- Seguin, TX
- Temple, TX
- Norfolk , VA
- Richmond, VA
- Tacoma, WA
- Madison, WI
|
|
 |
|
