Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

581 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2008-02-29

Brief Summary

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Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.

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Detailed Description

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Conditions

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Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zoledronic Acid 2x5 mg

Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12

Group Type EXPERIMENTAL

Zoledronic Acid

Intervention Type DRUG

Zoledronic acid 5 mg intravenous

Zoledronic Acid 1x5 mg

Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12

Group Type EXPERIMENTAL

Zoledronic Acid

Intervention Type DRUG

Zoledronic acid 5 mg intravenous

Placebo

Intervention Type DRUG

Physiologic 0.9% normal saline

Placebo

Placebo given at randomization and Month 12

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Physiologic 0.9% normal saline

Interventions

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Zoledronic Acid

Zoledronic acid 5 mg intravenous

Intervention Type DRUG

Placebo

Physiologic 0.9% normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal
* Greater than or equal to 45 years of age
* Osteopenia (lumbar spine bone mineral density \[BMD\] T-score between -1.0 and -2.5, and BMD T-score \> -2.5 at the femoral neck)

Exclusion Criteria

* Patients 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

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No