EFFICACY AND SAFETY OF INTRAMUSCULAR NERIDRONATE IN OSTEOPOROTIC PATIENTS AFFECTED BY PARKINSON'S DISEASE

Conditions: Osteoporosis in patients affected by Parkinson's disaease at the stages 1-2-3-4 following Hoehn and Yahr criteria
MedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2010-018904-94-IT

Lead Sponsor: FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

° males and females aged between 65 and 80 °patients affected by Parkinson's disease following international guidelines, in treatment with levodopa and/or dopamine agonists ° spine or femoral neck BMD T-score (using DXA) at least < -2.5 ° previuos low adherence or gastric/oesophageal intolerance to oral bisphosphonates stopped at least 3 months before the enrolment written informed consent to the treatment
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
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

°patients in efficaciuos treatment with oral bisphosphonates or SERMS °patients in treatment with oestrogens, glucocorticoids, calcitonin during last 12 months ° previous femural osteoporotic fractures °patients affected by bone metabolic diseses othe than osteoporosis, osteomalacia, hyperparathyroidism, hypocalcemia ° affected by renal, cardiovascular or neoplastic diseases ° affected by neurological diuseases other than Parkinson's disease ° affected by Parkinson's disease at stages 0 and 5 following Hoehn and Yahr criteria

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and the improvement in lumbar BMD after 24 months of intramuscular neridronate at the monthly dose of 25 mg.;Secondary Objective: To evaluate the safety and the improvement in femural BMD after 24 months of intramuscular neridronate at the monthly dose pf 25 mg. To evaluate the ability of neridronate to prevent femural fractures in patients affected by Parkinson's disease. To evaluate the effects of intramuscular neridronate on markers of bone turnover in osteoporotic patients affected by Parkinson's disease. To evaluate the patients' adherence to the intramuscular treatment with neridronate.;Primary end point(s): IMprovement in luimbar BMD at 24 months

Secondary Outcome Measures