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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00051636




Registration number
NCT00051636
Ethics application status
Date submitted
14/01/2003
Date registered
15/01/2003
Date last updated
15/05/2012

Titles & IDs
Public title
Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
Scientific title
Randomized, Double-blind, Safety and Efficacy Trial With Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone Using Risedronate as a Comparator, Including an Extended Observational Period
Secondary ID [1] 0 0
ZOL446K2304
Secondary ID [2] 0 0
CZOL446H2304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paget's Disease of Bone 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zoledronic Acid
Treatment: Drugs - Risedronate
Treatment: Drugs - Placebo to Risedronate
Treatment: Drugs - Placebo to Zoledronic Acid
Treatment: Other - Calcium and Vitamin D

Experimental: Zoledronic Acid and Placebo to Risedronate - Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Active comparator: Risedronate and Placebo to Zoledronic Acid - Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.


Treatment: Drugs: Zoledronic Acid
Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.

Treatment: Drugs: Risedronate
Oral risedronate 30 mg capsules.

Treatment: Drugs: Placebo to Risedronate
Oral placebo of risedronate capsules.

Treatment: Drugs: Placebo to Zoledronic Acid
5 mL of sterile water one dose intravenous infusion.

Treatment: Other: Calcium and Vitamin D
Calcium and vitamin D supplements were supplied.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients Who Achieve Therapeutic Response at 6 Months.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28
Timepoint [1] 0 0
Baseline and day 28
Secondary outcome [2] 0 0
Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10
Timepoint [2] 0 0
Baseline and day 10
Secondary outcome [3] 0 0
Relative Change in Urine Alpha C-telopeptide (a-CTx) in ug/mmol at Day 10
Timepoint [3] 0 0
Baseline and day 10
Secondary outcome [4] 0 0
Time to First Therapeutic Response
Timepoint [4] 0 0
182 days
Secondary outcome [5] 0 0
Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline
Timepoint [5] 0 0
Baseline and day 28
Secondary outcome [6] 0 0
Change in Pain Severity Score
Timepoint [6] 0 0
Baseline and day 182
Secondary outcome [7] 0 0
Change in Pain Interference Score
Timepoint [7] 0 0
Baseline and day 182
Secondary outcome [8] 0 0
Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period
Timepoint [8] 0 0
8 years was the maximum
Secondary outcome [9] 0 0
Number of Participants With a Partial Disease Relapse During the Extended Observation Period
Timepoint [9] 0 0
8 years was the maximum
Secondary outcome [10] 0 0
Number of Participants With a Disease Relapse During the Extended Observation Period
Timepoint [10] 0 0
8 years was the maximum

Eligibility
Key inclusion criteria
* 30 years or older
* Serum alkaline phosphatase (SAP) 2 times upper limit normal (ULN)
* Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.).
* 90 days washout calcitonin
* 180 day washout bisphosphonate
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Allergic reaction to bisphosphonates
* History of upper gastrointestinal disorders
* History of iritis, uveitis
* Calculated creatinine clearance < 30 ml/min at baseline
* Evidence of vitamin D deficiency

Other protocol-defined inclusion/exclusion criteria applied.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2011
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Concord
Recruitment hospital [2] 0 0
Novartis Investigative Site - Fitzroy
Recruitment hospital [3] 0 0
Novartis Investigative site - Geelong
Recruitment hospital [4] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [5] 0 0
Novartis Investigative site - Maroochydore
Recruitment hospital [6] 0 0
Novartis Investigative site - Nedlands
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Geelong
Recruitment postcode(s) [4] 0 0
- Kogarah
Recruitment postcode(s) [5] 0 0
- Maroochydore
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Rhode Island
Country [11] 0 0
Canada
State/province [11] 0 0
Calgary
Country [12] 0 0
Canada
State/province [12] 0 0
London
Country [13] 0 0
Canada
State/province [13] 0 0
Montreal
Country [14] 0 0
Canada
State/province [14] 0 0
Ste-Foy
Country [15] 0 0
Canada
State/province [15] 0 0
Toronto
Country [16] 0 0
New Zealand
State/province [16] 0 0
Auckland
Country [17] 0 0
New Zealand
State/province [17] 0 0
Christchurch
Country [18] 0 0
Spain
State/province [18] 0 0
Salamanca
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Liverpool
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Manchester
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Nottingham
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Oxford
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Penarth
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Pernarth
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Stanmore
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Vale of Glamorgan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.
Trial website
https://clinicaltrials.gov/study/NCT00051636
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00051636