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

August 1, 2016 updated by: Novartis Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

581

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • E. Hanover, New Jersey, United States, 07936
        • For information regarding facilities, please contact the Central Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zoledronic Acid 2x5 mg
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
Drug: Zoledronic Acid
Zoledronic acid 5 mg intravenous
Experimental: Zoledronic Acid 1x5 mg
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12
Drug: Zoledronic Acid
Zoledronic acid 5 mg intravenous
Drug: Placebo
Physiologic 0.9% normal saline
Placebo Comparator: Placebo
Placebo given at randomization and Month 12
Drug: Placebo
Physiologic 0.9% normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, Month 24

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

August 18, 2005

First Submitted That Met QC Criteria

August 18, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446N2312

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteopenia

Clinical Trials on Zoledronic Acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe