bone metabolic pathology associated to kidney transplantation MedDRA version: 7.1 Level: LLT Classification code 10058972
Conditions
Interventions
Trade Name: Actonel semanal
Product Name: Actonel semanal
Pharmaceutical Form: Coated tablet
INN or Proposed INN: risedronate
Other descriptive name: risedronic acid
Concentration unit: mg milligram(s
Sponsors
Dr. Jose Vicente Torregrosa Prats (fundacio clinic)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female aged 18-75 years old; chronic renal failure's patients on dialysis that have had a kidney transplant; patients who have been fully informed and have given written informed consent 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: Hyperimmunized patients (PRA ›75%); multiorganic transplant; diabetes mellitus patients on insulin treatment at the transplant moment; parathyroidectomised patients with parathyroid hormone values ‹ 50 pg/ml; patients that have received fluorine, biphosphonates or hormone replacement therapy in the previous 6 months, antiepileptic or calcitonin treatment in the previous 3 months, patients with biphosphonate allergy history, dyspepsia or reflux history and pregnant patients or nursing mothers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: study the efficacy of risedronate 35 mg/week to reduce the bone mass loss in patients after kidney transplantation;Secondary Objective: study the efficacy of risedronate 35 mg/week in bone fractures prevention and in the vascular calcifications of kidney graft recipients. Safety evaluation;Primary end point(s): bone masses evolutions through bone densitometry tests: basal and after 6 and 12 months | — |
Countries
Spain
Outcome results
None listed