A 2-year randomized, multicenter, double-blind, placebocontrolled study to determine the efficacy and safety of intravenous zoledronic acid 5 mg administered either annually at randomization and 12 months, or administered at randomization only in the prevention of bone loss in postmenopausal women with osteopenia - 2312

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000638-35-SE

Enrollment

582

Registered

2004-07-29

Start date

2004-09-15

Completion date

Unknown

Last updated

2012-05-29

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

Conditions

Postmenopausal Osteoporosis

Interventions

Product Name: zoledronic acid Product Code: ZOL446 Pharmaceutical Form: Intravenous infusion INN or Proposed INN: zoledronic acid Concentration unit: mg/ml milligram(s)/millilitre Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women greater than or equal to 45 years of age inclusive at the time of randomization, considered postmenopausal according to one of the following guidelines: • cessation of menses for 18 months in women =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patiens with more than one Grade 1 vertebral fracture (as per Genant method; patients with one Grade 1 vertebral fracture are eligible to participate) Patients with any Grade 2 or 3 vertebral fracture (as per Genant method) Patients with 25-(OH) Vitamin D levels less than 15 ng/mL prior to randomization Renal insufficiency (calculated creatinine clearance less than 30.0 mL/min) at Visit 1 or Visit 2 Hypercalcemia (serum calcium = 2.75 mmol/L (11.0 mg/dL) at Visit 1 Hypocalcemia (serum calcium = 2.0 mmol/L (8.0 mg/dL) at Visit 1 AST or ALT greater than 2.0 times the upper limit of normal Serum alkaline phosphatase greater than 1.5 times the upper limit of normal

Design outcomes

Primary

Measure	Time frame
Main Objective: - To demonstrate that zoledronic acid 5 mg i.v. given annually at randomization and Month 12 is superior to placebo in percent change of BMD at the lumbar spine at Month 24 relative to baseline in Stratum I (women < 5 years from menopause) and in Stratum II (women = 5 years from menopause) - To demonstrate that zoledronic acid 5 mg i.v. given at randomization only is superior to placebo in percent change of BMD at the lumbar spine at Month 24 relative to baseline in Stratum I and in Stratum II;Secondary Objective: To assess the percent change in BMD at the lumbar spine at Months 6, 12 and 18 relative to baseline in each strata comparing: a) zoledronic acid 5 mg i.v. given at randomization and Month 12 to placebo b) zoledronic acid 5 mg i.v. given at randomization only to placebo c) zoledronic acid 5 mg i.v. given at randomization only to zoledronic acid 5 mg i.v. given at randomization and Month 12 (including Month 24 for this comparison) To assess the percent change in BMD at the total hip, femoral neck, trochanter, and distal radius at Months 6, 12, 18, and 24 relative to baseline in each strata comparing: (a), (b) and (c) - see above. To assess the change of biochemical markers of bone resorption and formation at Months 1, 3, 6, 9, 12, 15, 18, and 24 relative to baseline in each strata comparing: (a), (b) and (c) - see above. To evaluate the overall safety and tolerability of zoledronic acid compared to placebo.;Primary end point(s): Change of BMD at the lumbar spine.	—

Measure

Time frame

Main Objective: - To demonstrate that zoledronic acid 5 mg i.v. given annually at randomization and Month 12 is superior to placebo in percent change of BMD at the lumbar spine at Month 24 relative to baseline in Stratum I (women < 5 years from menopause) and in Stratum II (women = 5 years from menopause) - To demonstrate that zoledronic acid 5 mg i.v. given at randomization only is superior to placebo in percent change of BMD at the lumbar spine at Month 24 relative to baseline in Stratum I and in Stratum II;Secondary Objective: To assess the percent change in BMD at the lumbar spine at Months 6, 12 and 18 relative to baseline in each strata comparing: a) zoledronic acid 5 mg i.v. given at randomization and Month 12 to placebo b) zoledronic acid 5 mg i.v. given at randomization only to placebo c) zoledronic acid 5 mg i.v. given at randomization only to zoledronic acid 5 mg i.v. given at randomization and Month 12 (including Month 24 for this comparison) To assess the percent change in BMD at the total hip, femoral neck, trochanter, and distal radius at Months 6, 12, 18, and 24 relative to baseline in each strata comparing: (a), (b) and (c) - see above. To assess the change of biochemical markers of bone resorption and formation at Months 1, 3, 6, 9, 12, 15, 18, and 24 relative to baseline in each strata comparing: (a), (b) and (c) - see above. To evaluate the overall safety and tolerability of zoledronic acid compared to placebo.;Primary end point(s): Change of BMD at the lumbar spine.

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Countries

Spain, Sweden

Outcome results

None listed

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