Skip to main content
OpenTrials
Completed

NCT Number: NCT00132808

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

For information regarding facilities, please contact the Central Contact

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zoledronic acid

Drug

Zoledronic acid 5 mg intravenous

Placebo

Drug

Physiologic 0.9% normal saline

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Aug 22, 2005
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.