Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01348243
• Date of registration: 04/05/2011
• Primary sponsor: Chiesi Farmaceutici S.p.A.
• Public title: Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis
• Scientific title: 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
• Date of first enrolment: October 2011
• Target sample size: 260
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01348243
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Italy

Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Postmenopausal Osteoporosis

Intervention(s)

Drug: Disodium clodronate 100 mg/3,3 ml with 1% lidocaine

Drug: disodium clodronate 200 mg/4 ml with 1% lidocaine

Primary Outcome(s)

Lumbar Bone Mineral Density [Time Frame: one year]

Secondary ID(s)

MC/PR/9900/004/10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors