Transient osteoporosis of the hip. MedDRA version: 20.0 Level: LLT Classification code 10077555 Term: Transient osteoporosis System Organ Class: 100000004851
Conditions
Interventions
Trade Name: NERIXIA - 100 MG CONCENTRATO PER SOLUZIONE PER INFUSIONE 2 FIALE
Product Name: Nerixia
Product Code: [035268022]
Pharmaceutical Form: Concentrate for solution for infusion
INN or Propose
Sponsors
ABIOGEN PHARMA S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PRIMARY OBJECTIVE OF EFFICACY: Evaluate the efficacy of treatment with Neridronate 100 mg, for 4 i.v. infusions, over a period of 10 days (i.e. at day 1, 4, 7 and 10) up to a total of 400 mg, compared to the treatment with Placebo, in the remission of spontaneous pain symptom, associated with transient osteoporosis of the hip.;Secondary Objective: SECONDARY OBJECTIVES OF EFFICACY: -To assess the intensity of the pain symptomatology; -To assess the improvement of quality of life; -To assess the improvement of the functional state of the affected hip compared to baseline; -To assess the rescue analgesic consumption (Paracetamol); -To assess the safety and tolerability of Neridronate i.v. infusions; -To assess the effect of treatment on Body Mass Index (BMI).;Primary end point(s): PRIMARY END POINTS: Reduction = 50% in spontaneous pain on a visual-analog scale of Huskisson (VAS) of 100 mm (0= no pain; 100= strong pain), from baseline (Visit 2) to the last visit of the double-blind randomized phase (Visit 6).;Timepoint(s) of evaluation of this end point: 30 days after the first infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): SECONDARY END POINTS: - Measurements of the intensity of the pain symptomatology on a VAS scale of 100 mm, will be also recorded at V2, V3, V4, V5, V7/V7A, V7B, V7C, V7D, V7E, V8/V8A; - Measurements of the intensity of pain symptoms, expressed through the score, derived from the Short-Form McGill Pain questionnaire, will be evaluated at V2, V6, V7/V7A, V7E, V8/V8A, V9; - Improvement of quality of life, by SF-36 questionnaire, will be evaluated at V2, V6, V7/V7A, V7E, V8/V8A, V9; - Change of the functional state of the affected hip, by WOMAC questionnaire, will be evaluated at V2, V6, V7/V7A, V7E, V8/V8A, V9; - Paracetamol use will be evaluated from V2 to V6 in double blind phase (for all patients) and from V6 to V7E in the open label phase (applicable only for patients who will take Neridronate, in open label phase); in case of discontinuation, until subject remains in the study; - Body Mass Index (BMI) will be evaluated at V1, V7/V7A, V8/V8A, V9.;Timepoint(s) of evaluation of this end point: see section E.5.2 | — |
Countries
Italy
Contacts
Public ContactClinical Operation
Phidealive S.r.l.
Outcome results
None listed