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

Osteopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132808
• Other study ID #: CZOL446N2312
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2005
• Last updated: July 31, 2012
• Start date: July 2004
• Est. completion date: February 2008

Study information

• Verified date: July 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 581
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteopenia

Intervention

Drug:
• Zoledronic Acid
Zoledronic acid 5 mg intravenous
• Placebo
Physiologic 0.9% normal saline

Locations

Country	Name	City	State
United States	For information regarding facilities, please contact the Central Contact	E. Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes