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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00132808
First Posted: August 22, 2005
Last Update Posted: September 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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.

Condition Intervention Phase
Osteopenia Drug: Zoledronic Acid Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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).

  • 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).

  • 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.

  • 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.

  • 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.


Enrollment: 581
Study Start Date: July 2004
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132808


Locations
United States, New Jersey
For information regarding facilities, please contact the Central Contact
E. Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00132808     History of Changes
Other Study ID Numbers: CZOL446N2312
First Submitted: August 18, 2005
First Posted: August 22, 2005
Results First Submitted: December 10, 2010
Results First Posted: January 10, 2011
Last Update Posted: September 12, 2016
Last Verified: August 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Postmenopausal osteoporosis
osteopenia
zoledronic acid
Osteopenia (osteoporosis prevention)

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs