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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000248-25-HU

Enrollment

900

Registered

2004-08-04

Start date

2004-08-04

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

corticosteroid induced osteoporosis

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion 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

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 2 weeks but <8 weeks) 2 months (if used <2 weeks) • Any prior use of i.v. bisphosphonate within 2 years prior to randomization

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Czech Republic, Hungary, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026