Trial information
A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
Status: Completed
Protocol number: ML19334
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized double-blind study to determine the time to onset of suppression of the bone resorption marker sCTX with once-monthly Boniva (ibandronate) versus placebo in the treatment of post-menopausal osteoporosis
Brief summary: This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 63.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandondronate [Bonviva/Boniva]
Primary outcome: 1. Percentage of patients whose sCTX concentration decreases by >=8%. Time frame: Day 3
Key secondary outcomes: 1. Percentage of patients whose sCTX concentration decreases by >=8% Time frame: Throughout study
2. Change in BSAP Time frame: Throughout study
3. Change in PTH Time frame: Month 1 Day 7, and Month 6 Day 7.
4. AEs and laboratory parameters Time frame: Throughout study
Inclusion criteria:
- women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment;
- naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening.
Exclusion criteria:
- patients on HRT within the last 3 months;
- patients on other osteoporosis medication within the last 3 months;
- sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level;
- hypersensitivity to any component of ibandronate;
- contraindication for calcium or vitamin D therapy;
- history of major gastrointestinal upset;
- malignant disease diagnosed within the previous 10 years (except resected basal cell cancer).
Gender: Females
Age limits: Min: 65 Years Max: N/A (No limit)
Accepts healthy volunteers: Yes
Trial registration date: 03/16/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Beverly Hills, CA
- La Jolla, CA
- Augusta, GA
- Woodbury, MN
- Bronx, NY
- Hopwood, PA
- Ponce, PR
- San Juan, PR
- Madison, WI
