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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	2 February 2015
Main ID:	EUCTR2004-000248-25-ES
Date of registration:	26/04/2005
Prospective Registration:	No
Primary sponsor:	Novartis Pharma AG
Public title:	A multinational, multicenter, randomized, double-blind, double-dummy, stratified, active controlled parallel group study comparing the efficacy and safety of intravenous zoledronic acid, 5 mg once yearly, and oral risedronate, 5 mg daily, in the prevention and treatment of corticosteroid induced osteoporosis - 2306
Scientific title:	A multinational, multicenter, randomized, double-blind, double-dummy, stratified, active controlled parallel group study comparing the efficacy and safety of intravenous zoledronic acid, 5 mg once yearly, and oral risedronate, 5 mg daily, in the prevention and treatment of corticosteroid induced osteoporosis - 2306
Date of first enrolment:	04/11/2004
Target sample size:	900
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000248-25
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: yes Cross over: Other: If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other:
Phase:

Countries of recruitment
Czech Republic	Hungary	Spain

Contacts

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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
(for full list see protocol):
• Male and female patients 18 to 85 years age old
• Patients treated with at least 7.5 mg of oral prednisone per day (or equivalent systemic corticosteroid) and expected to continue corticosteroids therapy for at least a 12 month period:
Treated for less or equal to 3 months prior to study entry (prevention sub-population)
Treated for more than 3 months prior to study entry (treatment sub-population).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
(for full list see protocol):
• Any prior use of bisphosphonate preparations except according to the washout schedule at
time of randomization:
2 years (if use >48 weeks)
1 year (if used >8 weeks but <48 weeks)
6 months (if used >2 weeks but <8 weeks)
2 months (if used <2 weeks)
• Any prior use of i.v. bisphosphonate within 2 years prior to randomization

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

corticosteroid induced osteoporosis

Intervention(s)

Product Name: zoledronic acid
Product Code: ZOL446
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: zoledronic acid
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.05-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Actonel
Product Name: Actonel
Product Code: --
Pharmaceutical Form: Capsule*
INN or Proposed INN: risedronate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.0-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: to demonstrate that the percent change in lumbar spine BMD at Month 12 relative to baseline in male and female patients treated with one iv zoledronic acid 5 mg dose at randomization is not inferior to the percent change in lumbar spine BMD at Month 12 compared to baseline in those patients who are treated with oral risedronate 5 mg daily.

Secondary Objective: • To assess the percent change in BMD at the total hip, femoral neck, trochanter, and distal
radius at Month 6 and Month 12 relative to baseline in patients treated with zoledronic acid
compared to patients treated with risedronate.
• To assess changes in biochemical markers of the bone turnover at Day 10, Month 3, Month 6, and Month 12 relative to baseline in patients treated with zoledronic acid compared to patients treated with risedronate.
• To evaluate the overall safety of zoledronic acid compared to risedronate in patients receiving corticosteroid therapy.

Primary end point(s): • DXA measurements of the lumbar spine, hip and distal radius at baseline, Months 6 and 12.
• Height Measurements at baseline, Months 6 and 12.
• Bone Marker Analysis (specialized serum tests for CTx, P1NP, bone specific alkaline
phosphatase and urinary NTx - markers associated with osteoporosis yet to be identified could
be performed in addition) prior to receiving the first dose of study drug and at all subsequent
visits until Month 12.
• Clinical and morphometric fractures
• Lateral X-ray of the lumbar and thoracic spine to assess vertebral fractures at baseline and month 12

Secondary Outcome(s)

Secondary ID(s)

2004-000248-25-HU

CZOL446O2306

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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