Trial Outcomes & Findings for Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast® (NCT NCT00668200)
NCT ID: NCT00668200
Last Updated: 2015-03-06
Results Overview
To be included in the analysis, patients were required to have a baseline serum calcium of at least 2.07 mmol/L and at least one serum calcium measurement 9-11 days post-infusion of zoledronic acid. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used. hypocalcemia was defined as treatment-emergent serum calcium \<2.07 mmol/L at 9-11 days after the study drug infusion.
COMPLETED
PHASE4
81 participants
at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
2015-03-06
Participant Flow
Participant milestones
| Measure |
Zoledronic Acid
5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
Safety Population
|
81
|
|
Overall Study
Intent to Treat (ITT)
|
80
|
|
Overall Study
COMPLETED
|
77
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Zoledronic Acid
5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®
Baseline characteristics by cohort
| Measure |
Zoledronic Acid
n=80 Participants
5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
|
|---|---|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 12.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)Population: Safety population which includes 81 patients was used. 75 of the 81 patients in the safety population met the criteria. 6 patients did not meet criteria and were excluded from the analysis: 1 patient had a low serum calcium at baseline, and the other 5 patients were missing serum calcium values either at baseline or post-baseline.
To be included in the analysis, patients were required to have a baseline serum calcium of at least 2.07 mmol/L and at least one serum calcium measurement 9-11 days post-infusion of zoledronic acid. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used. hypocalcemia was defined as treatment-emergent serum calcium \<2.07 mmol/L at 9-11 days after the study drug infusion.
Outcome measures
| Measure |
Zoledronic Acid
n=75 Participants
5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
|
|---|---|
|
Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.
Visit 2
|
1.3 percentage of patients
|
|
Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.
Visit 3
|
0.0 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)Population: This Outcome Measure uses Safety population which includes 81 patients. During monitoring it was discovered that one patient signed the consent form from another Paget's study; therefore, this patient was excluded from the ITT population but included in the safety. The ITT population was used for participant flow and baseline characteristics.
Change from baseline = endpoint - baseline, at each time point, only participants with a value at baseline and that time point are included in the change from baseline column. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used.
Outcome measures
| Measure |
Zoledronic Acid
n=81 Participants
5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
|
|---|---|
|
Change From Baseline in Serum Calcium (mmol/L) - Safety Population
Visit 2 n=76
|
-0.024 mmol/L
Standard Deviation 0.189
|
|
Change From Baseline in Serum Calcium (mmol/L) - Safety Population
Visit 3 n=2
|
0.04 mmol/L
Standard Deviation 0.014
|
SECONDARY outcome
Timeframe: End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30)Population: This Outcome Measure uses Safety population which includes 81 patients. During monitoring it was discovered that one patient signed the consent form from another Paget's study; therefore, this patient was excluded from the ITT population but included in the safety. The ITT population was used for participant flow and baseline characteristics.
The end of study is not a separate time point. It is the last post-baseline, for majority the end of study was visit 2. There were 2 patients who had the end of study at Visit 3. If calcium at visit 2 was abnormal it was measured again at visit 3.
Outcome measures
| Measure |
Zoledronic Acid
n=81 Participants
5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
|
|---|---|
|
Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
Tingling around your mouth n=76
|
1.3 percentage of patients
|
|
Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
Tingling in fingers n=66
|
3 percentage of patients
|
|
Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
Cramps in hands n=62
|
3.2 percentage of patients
|
|
Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
Cramps in leg or feet n=50
|
0 percentage of patients
|
|
Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
Involuntary movements of hands n=73
|
2.7 percentage of patients
|
|
Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
Involuntary movements of feet n=70
|
1.4 percentage of patients
|
|
Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
Involuntary movements of facial muscles n=71
|
0 percentage of patients
|
|
Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
Generalized (epileptic) seizures n=76
|
0 percentage of patients
|
Adverse Events
Zoledronic Acid
Serious adverse events
| Measure |
Zoledronic Acid
n=81 participants at risk
5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
1.2%
1/81
|
Other adverse events
| Measure |
Zoledronic Acid
n=81 participants at risk
5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
|
|---|---|
|
General disorders
Acute phase reaction
|
7.4%
6/81
|
|
General disorders
Chills
|
12.3%
10/81
|
|
General disorders
Malaise
|
7.4%
6/81
|
|
General disorders
Pain
|
11.1%
9/81
|
|
General disorders
Pyrexia
|
6.2%
5/81
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.
- Publication restrictions are in place
Restriction type: OTHER