Osteoporosis
Conditions
Interventions
Trade Name: Fosamax Once Weekly 70 mg Tablets
Pharmaceutical Form: Tablet
Trade Name: Alendronic Acid 70 mg Tablets
Pharmaceutical Form: Tablet
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Post-menopausal women with osteoporosis, aged over 55 years, able to give consent and comply with the study requirements, and who have been prescribed alendronate for at least 3 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients taking any form of medication that alters upper gastrointestinal motility or having any physical condition that affects GI motility. Those patients should not exceed 5 mSv total radiation exposure per year by taking part in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish if there is a difference in oesophageal transit between the branded and generic alendronate tablets which are prescribed for the treatment of osteoporosis. ; Secondary Objective: To establish if: 1. there is a difference in gastric emptying times, and 2. there is a difference in dispersal of branded and generic alendronate tablets which are prescribed in the treatment of osteoporosis. ;Primary end point(s): Oesophageal transit time and incidences of tablet sticking | — |
Countries
United Kingdom
Outcome results
None listed