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

Novartis Pharmaceuticals581 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

581

Conditions

Osteopenia

Interventions

Zoledronic AcidDRUG

Zoledronic acid 5 mg intravenous

PlaceboDRUG

Physiologic 0.9% normal saline

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

For information regarding facilities, please contact the Central Contact

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline, Month 24

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Months 6, 12, 18 and 24

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.