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
Overview
- Phase
- Phase 3
- Intervention
- Zoledronic Acid
- Conditions
- Osteopenia
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 581
- Locations
- 1
- Primary Endpoint
- Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Zoledronic Acid 2x5 mg
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
Intervention: Zoledronic Acid
Zoledronic Acid 1x5 mg
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12
Intervention: Zoledronic Acid
Zoledronic Acid 1x5 mg
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12
Intervention: Placebo
Placebo
Placebo given at randomization and Month 12
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum
Time Frame: Baseline, Month 24
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).
Secondary Outcomes
- Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.(Baseline, Month 24)
- Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.(Baseline, Month 24)
- Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum(Months 6, 12, 18 and 24)
- Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum(Months 6, 12, 18 and 24)
- Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum(Months 6, 12, 18 and 24)