Postmenopausal OsteoporosisPhase 3NCT01348243
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
A Phase 3 study testing disodium clodronate 200 mg/4 ml with 1% lidocaine and Disodium clodronate 100 mg/3,3 ml with 1% lidocaine in people with Postmenopausal Osteoporosis, run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- disodium clodronate 200 mg/4 ml with 1% lidocaine and Disodium clodronate 100 mg/3,3 ml with 1% lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2011to Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject's written informed consent obtained prior to any study-related procedures;
- Postmenopausal (any menses in the last 5 years) female subjects > 50 years old with lumbar or femoral-neck T-score < -2,5 and > -4;
- At least three intact vertebrae between L1 and L4;
- Patients treated according to the non-pharmacological standard of care;
- Patients with the possibility and willingness to take the i.m. injections.
Who cannot join
- BMI < 19 kg/m2;
- 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;
- 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;
- Serious diseases of the oral cavity and surgery and/or dental implant from less than a month or planned in the next 12 months;
- Type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C >10,0), or currently using insulin;
- Family history of malignant hyperthermia;
Show all 20Show fewer
- 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;
- History of kidney failure or renal insufficiency (serum creatinine > 2,0 mg/dl);
- History of stroke in the last 6 months or uncontrolled hypertension;
- Any history of hypercalciuria;
- History of hypercalcemia, sarcoidosis, hyperparathyroidism, hypothyroidism or hyperthyroidism;
- History of any malignancy except epithelioma considered cured ;
- Patients currently treated with systemic prednisone or equivalent per day or > 2000 mcg beclomethasone dipropionate or equivalent daily; ;
- 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;
- Patients current treated with propanolol, cimetidine or digitalis drugs;
- History of alcohol or drug abuse;
- Allergy, sensitivity or intolerance to study drugs (included lidocaine or other amide-type local anaesthetics) or excipients;
- 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;
- Subjects who received any investigational new drug, or participated in clinical study within the last 12 weeks;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- disodium clodronate 200 mg/4 ml with 1% lidocaine, Disodium clodronate 100 mg/3,3 ml with 1% lidocaine
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disodium clodronate 200 mg/4 ml with 1% lidocaineDrug
CLODRONATE 200 MG/4 ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE EVERY OTHER WEEK
Disodium clodronate 100 mg/3,3 ml with 1% lidocaineDrug
CLODRONATE 100 MG/3,3 ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE ONCE-WEEK
| Study group | Role | What they receive |
|---|---|---|
| Clodronate 200 mg | Experimental | Not described Receives: Drug: disodium clodronate 200 mg/4 ml with 1% lidocaine |
| Clodronate 100 mg | Active comparator | Not described Receives: Drug: Disodium clodronate 100 mg/3,3 ml with 1% lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Bone Mineral Density
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348243
- Sponsor's protocol ID
- MC/PR/9900/004/10
- Other IDs
- 2010-022060-13
- Status last verified
- Mar 2017
- First submitted
- 4 May 2011
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01348243
- Acronym / sponsor ID
- MC/PR/9900/004/10
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clodronate 200 mg | Experimental | Drug: disodium clodronate 200 mg/4 ml with 1% lidocaine |
| Clodronate 100 mg | Active comparator | Drug: Disodium clodronate 100 mg/3,3 ml with 1% lidocaine |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject's written informed consent obtained prior to any study-related procedures;
- Postmenopausal (any menses in the last 5 years) female subjects > 50 years old with lumbar or femoral-neck T-score < -2,5 and > -4;
- At least three intact vertebrae between L1 and L4;
- Patients treated according to the non-pharmacological standard of care;
- Patients with the possibility and willingness to take the i.m. injections.
Key exclusion criteria (20 listed)
- BMI < 19 kg/m2;
- 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;
- 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;
- Serious diseases of the oral cavity and surgery and/or dental implant from less than a month or planned in the next 12 months;
- Type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C >10,0), or currently using insulin;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| disodium clodronate 200 mg/4 ml with 1% lidocaineCLODRONATE 200 MG/4 ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE EVERY OTHER WEEK | Drug | Clodronate 200 mg |
| Disodium clodronate 100 mg/3,3 ml with 1% lidocaineCLODRONATE 100 MG/3,3 ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE ONCE-WEEK | Drug | Clodronate 100 mg |
Primary outcome
Lumbar Bone Mineral Density
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing disodium clodronate 200 mg/4 ml with 1% lidocaine and Disodium clodronate 100 mg/3,3 ml with 1% lidocaine in people with Postmenopausal Osteoporosis, run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar Bone Mineral Density (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.