MULTICENTRE, RANDOMIZED, OPEN-LABEL, TWO-ARM PARALLEL GROUPS, ACTIVE CONTROLLED STUDY DESIGN TO DEMONSTRATE EFFICACY AND TOLERABILITY OF CLODRONATE 200 MG/4 ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE EVERY OTHER WEEK VS CLODRONATE 100 MG/3,3ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE ONCE-WEEK IN A 1-YEAR TREATMENT PERIOD OF WOMEN WITH POSTMENOPAUSAL OSTEOPOROSIS

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 326

Inclusion Criteria

1.Subject’s written informed consent obtained prior to any study-related procedures;
2.Postmenopausal (any menses in the last 5 years) female subjects = 50 years old with lumbar T-score < -2,5 and > -4 or femoral-neck T-score < -2,5 and > -3;
3.At least three intact vertebrae between L1 and L4 and two evaluable vertebrae for DXA;
4.Patients treated according to the non-pharmacological standard of care;
5.Patients with the possibility and willingness to take the i.m. injections

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 196
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

BMI < 19 kg/m2;
2. History of: ever use of intravenous bisphosphonates or strontium ranelate, more than 12 months of bisphosphonates (oral and intramuscular) continuatively , or any use of bisphosphonates (oral and intramuscular) within the last year, rhPTH use (recombinant human PTH) in the last 2 years, calcitonin use within the past 3 months, raloxifene and tamoxifen in the last 6 months or for more than 12 months in the last 2 years, fluoride (> 1 mg/die) for at least a month within the past 5 years;
3. Use of estrogen (oral or patch) for more than 1 month in the last 6 months or more than 12 months in the last 2 years;
4. Serious diseases of the oral cavity and surgery and/or dental implant from less than a month or planned in the next 12 months;
5. Type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C >10,0), or currently using insulin;
6. Family history of malignant hyperthermia;
7. Heart disease, particularly bradyarrhythmias and heart failure; Adams-Stokes syndrome, Wolff-Parkinson-White syndrome or severe degrees of sinoatrial, atrioventricular or intraventricular block, acute cardiac decompensation;
8. History of kidney failure or renal insufficiency (creatinine > 2,0 mg/dl)
9. History of stroke in the last 6 months or uncontrolled hypertension;
10. History of hypercalciuria;
11. History of hypercalcemia, sarcoidosis, hyperparathyroidism, hyperthyroidism or hypothyroidism (except for patients in conditions of euthyroidism taking stable dose of thyroid hormone from at least 6 weeks);
12. History of any malignancy except for epithelioma considered cured;
13. Patients currently treated with systemic corticosteroids or > 2000 mcg beclomethasone dipropionate or equivalent daily;
14. Patients currently treated with antiepileptic drugs and/or anticoagulants or treated in the last 6 months or for more than 12 months in the last 2 years;
15. Patients current treated with propanolol, cimetidine or digitalis drugs;
16. History of alcohol or drug abuse;
17. Allergy, sensitivity or intolerance to study drugs (included lidocaine or other amide-type local anaesthetics) or excipients;
18. Subjects unlikely to comply with the study protocol or unable to understand the nature and scope of the study but also the possible benefits or unwanted effects of the study treatments.
19. Subjects who received any investigational new drug, or participated in clinical study within the last 12 weeks.
20. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
21. Femoral-neck T-score < -3

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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