Clinical trial to evaluate the efficacy, safety and tolerability of Neridronate versus Placebo in patients with transient osteoporosis of the hip.

Phase 1

• Conditions: Transient osteoporosis of the hip.; MedDRA version: 20.0Level: LLTClassification code 10077555Term: Transient osteoporosisSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-003505-26-IT
• Lead Sponsor: ABIOGEN PHARMA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-18
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

INCLUSION CRITERIA:
1.Age of 18 years or older;
2.Ability to understand study objectives and all required study procedures;
3.Approval and signature of Informed Consent, prior to participating to the study;
4.Women of child-bearing potential must have a negative pregnancy test prior to starting the study and use adequate anticonceptive methods (for all women who already terminated pregnancy period, it’s mandatory that they have interrupted breastfeeding time, before participation to the study);
5.The diagnosis of transient osteoporosis of the hip will take place through the anamnestic data collection, the clinical examination, DEXA evaluation and hip bone MRI;
6.MRI should indicate the typical pattern of transient osteoporosis of the hip, which will show an extended and homogeneous area of reduced signal in T1 sequences, and of hyperintensity in T2 images at femoral head level, with possible extension to neck level and femoral intertrochanteric region;
7.Presence of spontaneous pain longer than 3 weeks and expressed by the patient, on the VAS scale, as equal to or greater than 50 mm.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

EXCLUSION CRITERIA:
1.Subjects with age < 18 years;
2.Severe inability to understand the study and to undergo to all necessary procedures;
3.Refuse to provide written informed consent, prior to participating to the study;
4.Women of childbearing potential who do not undergo pregnancy tests and do not use adequate anticonceptive methods;
5.Women of childbearing age with a positive pregnancy test, in a pregnant or breastfeeding status;
6.Other causes of coxalgia related to inflammatory joint diseases (rheumatoid arthritis, psoriatic or septic arthritis) or linked to stress fractures, villonodular synovitis, synovial chondromatosis;
7.Contemporary presence of osteometabolic diseases. The coexistence of initial coxarthrosis is not an exclusion criterium, for enrollment in the study;
8.Presence at MRI examination, of compatible alterations with aseptic osteonecrosis, with a changed profile of the articular surfaces;
9.Other diagnosis of osteonecrosis detected by instrumental examinations;
10.Blood calcium values, below standard parameters or a glomerular filtrate lower than 35 ml/min;
11.Positive history and/or evocative signs or symptoms for relevant diseases, related to ongoing organ failures (hepatic, renal, endocrine, haematological, cardiac, pulmonary or neurological failures);
12.Recent tooth extraction (in the past 3 months prior to Visit 1), unhealed or infected extraction site, significant dental/periodontal disease that may predispose to tooth extraction or other invasive dental procedures during the trial;
13.Evidence of denture-related gum trauma or injury;
14.Prior development of an allergic reaction/hypersensitivity to bisphosphonates;
15.Current treatment with bisphosphonates or in the previous 12 months;
16.Patient who received any new investigational drug within the last 12 weeks.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified