Antiresorptive Effects of a 6-m Treatment Course With Ibandronate Plus Supplementation of Vitamine D and Calcium in Central America
Completed
- Conditions
- Osteoporosis
- Interventions
- Drug: antiresorptive therapy
- Registration Number
- NCT02635997
- Lead Sponsor
- Pontifical Catholic University of Argentina
- Brief Summary
Ibandronate is a third-generation biphosphonate with recognized antiresorptive efficacy by several international, randomized, double-blind, controlled trials. These studies have not included patients from central america, to the best of our knowledge. Therefore, this open-label, uncontrolled study, was set out to assess the clinical effects of a 6-m treatment course with Ibandronate plus vitamine D and Calcium on bone mineral density and health-related quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 425
Inclusion Criteria
- Women with a diagnosis of osteoporosis of at-Risk
- Have a medical indication to receive Ibandronate+Vitamine D+Calcium
Exclusion Criteria
- Osteoporosis due to secondary causes
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients on antiresorptive therapy antiresorptive therapy Ibandronate 150 mg per month + Vitamine D 400-800 IU and Calcium 500-1000 mg per day
- Primary Outcome Measures
Name Time Method Bone Mineral Density 6 months Health-Related Quality of Life 6 months
- Secondary Outcome Measures
Name Time Method Adverse Events 6 months
Trial Locations
- Locations (1)
Catholic University
🇦🇷Buenos Aires, Argentina
Catholic University🇦🇷Buenos Aires, Argentina