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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00132808
First received: August 18, 2005
Last updated: July 31, 2012
Last verified: July 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00132808     History of Changes
Other Study ID Numbers: CZOL446N2312
Study First Received: August 18, 2005
Results First Received: December 10, 2010
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 01, 2014