Clinical trial NCT01348243 (phase 3, status: completed)
Conditions: postmenopausal osteoporosis
ICD codes: N95.0, N95.2
Drugs: disodium clodronate 200 mg/4 ml with 1% lidocaine, disodium clodronate 100 mg/3,3 ml with 1% lidocaine
SMILES: OP(O)(=O)C(Cl)(Cl)P(O)(O)=O, OP(O)(=O)C(Cl)(Cl)P(O)(O)=O
Eligibility criteria:

        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 or femoral-neck T-score < -2,5 and > -4;

          3. At least three intact vertebrae between L1 and L4;

          4. Patients treated according to the non-pharmacological standard of care;

          5. Patients with the possibility and willingness to take the i.m. injections.

        Exclusion Criteria:

          1. BMI < 19 kg/m2;

          2. History of: use of intravenous bisphosphonates, more than 12 months of bisphosphonates
             continuative or strontium ranelate use ever, or any use of bisphosphonates (oral and
             injective) 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 (serum creatinine > 2,0 mg/dl);

          9. History of stroke in the last 6 months or uncontrolled hypertension;

         10. Any history of hypercalciuria;

         11. History of hypercalcemia, sarcoidosis, hyperparathyroidism, hypothyroidism or
             hyperthyroidism;

         12. History of any malignancy except epithelioma considered cured ;

         13. Patients currently treated with systemic prednisone or equivalent per day or > 2000
             mcg beclomethasone dipropionate or equivalent daily; ;

         14. Patients currently treated with antiepileptic drugs, anticoagulants or anticonvulsants
             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.