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

Study Overview
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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.

Official Title
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A 2-year Randomized, Multicenter, Double-blind, Placebo-controlled 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

Conditions
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Osteopenia

Intervention / Treatment
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* Drug: Zoledronic Acid
* Drug: Placebo


Participation Criteria
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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 Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zoledronic Acid 2x5 mg<br>Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12 | Drug: Zoledronic Acid<br>* Zoledronic acid 5 mg intravenous<br>|
| Experimental: Zoledronic Acid 1x5 mg<br>Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12 | Drug: Zoledronic Acid<br>* Zoledronic acid 5 mg intravenous<br>Drug: Placebo<br>* Physiologic 0.9% normal saline<br>|
| Placebo Comparator: Placebo<br>Placebo given at randomization and Month 12 | Drug: Placebo<br>* Physiologic 0.9% normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum | The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month - lumbar spine BMD at baseline) / (lumbar spine BMD at baseline). | Baseline, Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum. | The percentage change in total hip BMD at Month 24 relative to baseline was derived as 100 x (total hip BMD at 24 Month - total hip BMD at baseline) / (total hip BMD at baseline). | Baseline, Month 24 | 
| Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum. | The percentage change in femoral neck BMD at Month 24 relative to baseline was derived as 100 x (femoral neck BMD at 24 Month - femoral neck BMD at baseline) / (femoral neck BMD at baseline). | Baseline, Month 24 | 
| Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Biomarker: Serum b-CTx levels at Months 6, 12, 18 and 24 by stratum. | Months 6, 12, 18 and 24 | 
| Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Biomarker: Serum P1NP levels at Months 6, 12, 18 and 24 by stratum. | Months 6, 12, 18 and 24 | 
| Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum. | Months 6, 12, 18 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal osteoporosis, osteopenia, zoledronic acid, Osteopenia (osteoporosis prevention)