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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018904-94-IT

Enrollment

Registered

2012-03-14

Start date

2010-05-31

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis in patients affected by Parkinson's disaease at the stages 1-2-3-4 following Hoehn and Yahr criteria MedDRA version: 14.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: NERIXIA*IM EV 1F 25MG Pharmaceutical Form: Solution for injection INN or Proposed INN: Bisphosphonates Other descriptive name: Neridronic acid Concentration unit: mg milligram(s) Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026