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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

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ClinicalTrials.gov Identifier: NCT01348243
Recruitment Status : Completed
First Posted : May 5, 2011
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Tracking Information
First Submitted Date  ICMJE May 4, 2011
First Posted Date  ICMJE May 5, 2011
Last Update Posted Date March 30, 2017
Study Start Date  ICMJE October 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2011)
Lumbar Bone Mineral Density [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary

Clodronic acid 100 mg/3,3 ml is used to prevent and treat postmenopausal osteoporosis.

The intramuscular formulation, which is given at a dose of 100 mg every 7 o 14 days, is at least as effective as daily oral therapy and appears more effective than intermittent intravenous treatment. Intramuscular clodronic acid in particular has also been associated with improvements in back pain. The drug is well tolerated, with no deleterious effects on bone mineralization, and use of parenteral therapy eliminates the risk of gastrointestinal adverse effects that may be seen in patients receiving oral bisphosphonates therapy.

In order to simplify the therapeutic dosing regimen, reducing the number of administrations per month, and therefore increase adherence to bisphosphonates therapy of the patient, a new formulation of disodium clodronic acid containing 200 mg/4 mL for i.m. administration has been developed. Lidocaine in this new formulation, as local anaesthetic, is maintained at the same concentration as in the 100 mg clodronic acid formulation.

The pharmacokinetics and tolerability of the intramuscular formulation of clodronic acid 200 mg in comparison to the marketed formulation clodronic acid 100 mg was evaluated in healthy post-menopausal volunteers. Two formulations were similar in terms of amount and rate of clodronic acid urinary excretion and in terms of safety profile.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postmenopausal Osteoporosis
Intervention  ICMJE
  • Drug: disodium clodronate 200 mg/4 ml with 1% lidocaine
    CLODRONATE 200 MG/4 ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE EVERY OTHER WEEK
  • Drug: Disodium clodronate 100 mg/3,3 ml with 1% lidocaine
    CLODRONATE 100 MG/3,3 ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE ONCE-WEEK
Study Arms  ICMJE
  • Experimental: Clodronate 200 mg
    Intervention: Drug: disodium clodronate 200 mg/4 ml with 1% lidocaine
  • Active Comparator: Clodronate 100 mg
    Intervention: Drug: Disodium clodronate 100 mg/3,3 ml with 1% lidocaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2011)
260
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01348243
Other Study ID Numbers  ICMJE MC/PR/9900/004/10
2010-022060-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Chiesi Farmaceutici S.p.A.
Original Responsible Party Eleonora Ingrassia, Chiesi Farmaceutici
Current Study Sponsor  ICMJE Chiesi Farmaceutici S.p.A.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP