Liver cirrhosis, esophageal varices , osteoporosis, osteopenia
Conditions
Interventions
The subjects of the intervention group, consisting of 21 patients with hepatic cirrhosis, esophageal varices and osteoporosis, will receive weekly dose of 1 tablet of risedronate 35 mg orally, fasted
Drug
Procedure/surgery
Sponsors
Fundação de amparo a pesquisa do estado de São Paulo- FAPESP
Faculdade de Medicina de Botucatu - UNESP
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Volunteers with hepatic cirrhosis, esophageal varices and osteoporosis or osteopenia; age greater than 18 years; physical and mental conditions of ingesting medications; agreement to sign the informed consent form.
Exclusion criteria
Exclusion criteria: Severe psychiatric illness; upper gastrointestinal bleeding in the last 6 months; esophageal varices of large caliber; renal insufficiency; active peptic ulcer; esophageal stricture; achalasia; gastroparesis; current use of anti-inflammatories, anticoagulants, platelet anti-aggregants and alcoholic beverage; gestation or lactation; neoplasms of the esophagus, stomach or duodenum; hypersensitivity to bisphosphonates; absolute contraindication to endoscopy; advanced cirrhosis; advanced hepatic encephalopathy; previous liver transplantation; use of hormone replacement therapy; primary hyperparathyroidism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of digestive hemorrhage during follow-up, clinically verified by the presence of vomiting of red, dark or coagulated blood (coffee ground vomitus), and by evacuation of blackened feces with a foul smell or by evacuation of red blood. It also can be confirmed by direct visualization of bleeding in the lumen of the gastrointestinal tract by upper digestive endoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of lesions in the esophagus, stomach and duodenum during the follow-up related to the use of residronate, verified by upper digestive endoscopy from the observation of esophagitis, gastrites, ulcers or duodenitis.;Occurrence of gastrointestinal or musculoskeletal complaints related to the use of risedronate, verified through a questionnaire on the appearance of symptoms throughout the follow-up, such as heartburn, burning, abdominal pain, nausea, vomiting and muscle or joint pain. | — |
Countries
Brazil
Contacts
Public ContactTalles Lima
Faculdade de Medicina de Botucatu - UNESP
Outcome results
None listed