Phase 3
N=224
Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older
Osteopenia
Bottom Line
View on ClinicalTrials.gov: NCT00132808 ↗Enrolled (actual)
224
Serious AEs
10.5%
Results posted
Jan 2011
Primary outcome: Primary: Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum — 4.62; 4.03; -2.24; 5.60 Percentage change in BMD
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zoledronic Acid (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum |
4.62; 4.03; -2.24; 5.60; 4.76; -0.65 | — |
| SECONDARY Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum. |
2.66; 2.55; -2.10; 3.04; 2.11; -1.04 | — |
| SECONDARY Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum. |
2.04; 2.01; -1.55; 2.35; 1.46; -1.18 | — |
| SECONDARY Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum |
0.2217; 0.2286; 0.6439; 0.2861; 0.3111; 0.6634 | — |
| SECONDARY Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum |
20.851; 20.752; 59.449; 28.231; 30.500; 55.166 | — |
| SECONDARY Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum |
8.718; 8.841; 13.982; 9.945; 10.539; 14.127 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00132808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.