a randomised, open clinical trial to study the efficacy of risedronate 35 mg/week in prevention of bone mass loss and vascular calcifications after kidney transplantationEnsayo aleatorio, abierto para estudiar la eficacia de risedronato 35mg/semanal en la prevención de pérdida de masa ósea y calcificaciones vasculares post-trasplante renal - PREVENOS
- Conditions
- MedDRA version: 7.1Level: LLTClassification code 10058972bone metabolic pathology associated to kidney transplantation
- Registration Number
- EUCTR2004-002852-33-ES
- Lead Sponsor
- Dr. Jose Vicente Torregrosa Prats (fundacio clinic)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method