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

Phase 3

Completed

• Conditions: Osteopenia
• Interventions: Drug: Zoledronic Acid; Drug: Placebo

• Registration Number: NCT00132808
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-08-18
• Study First Submitted QC: 2005-08-18
• Study First Posted: 2005-08-22
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2010-12-10
• Results First Submitted QC: 2010-12-10
• Results First Posted: 2011-01-10
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 581

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoledronic Acid 1x5 mg	Placebo	Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12
Placebo	Placebo	Placebo given at randomization and Month 12
Zoledronic Acid 2x5 mg	Zoledronic Acid	Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
Zoledronic Acid 1x5 mg	Zoledronic Acid	Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12

Primary Outcome Measures

Name	Time	Method
Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum	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 Outcome Measures

Name	Time	Method
Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.	Baseline, Month 24	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).
Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.	Baseline, Month 24	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).
Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum	Months 6, 12, 18 and 24	Biomarker: Serum P1NP levels at Months 6, 12, 18 and 24 by stratum.
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum	Months 6, 12, 18 and 24	Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum.
Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum	Months 6, 12, 18 and 24	Biomarker: Serum b-CTx levels at Months 6, 12, 18 and 24 by stratum.

Trial Locations

Locations (1)

For information regarding facilities, please contact the Central Contact; 🇺🇸 E. Hanover, New Jersey, United States