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A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00909961
First received: May 28, 2009
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical markers of bone in post-menopausal osteoporotic patients aged between 50-65.


Condition Intervention Phase
Postmenopausal Osteoporosis
 Drug: Zoledronic acid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A One Year, Local, Open Label, Multicentre Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on BMD and Biochemical Markers of Bone in PMO Pts Between the Ages of 50 and 65 Years

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Efficacy - BMD [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy - Biochemical markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety - Rate of adverse events and serious adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 118
Study Start Date: November 2009
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoledronic acid Drug: Zoledronic acid

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal osteoporosis
  • Patients who has a low bone mineral density at hip or vertebral
  • Patients who has an osteoporotic fracture at hip or vertebra

Exclusion Criteria:

  • Hypersensitivity either to the active substance or to any of the excipients or to any biphosphonates.
  • Known metabolic bone disease excluding osteoporosis.
  • Serious systemic disorder treated with drugs interfering with bone metabolism.
  • Significant liver or renal failure
  • Pathologic fracture in the examined body area or elsewhere.
  • Previous anti-osteoporotic treatment within 12 months or less prior to the recruitment.
  • Patients with hypocalcaemia

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909961

Locations
Turkey
Novartis Investigational site
Ankara, Turkey
Novartis Investigative site
Antalya, Turkey
Novartis Investigational site
Istanbul, Turkey
Novartis Investigative site
Izmir, Turkey
Novartis Investigative site
Kayseri, Turkey
Novartis Investigative site
Konya, Turkey
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00909961     History of Changes
Other Study ID Numbers: CZOL446HTR04
Study First Received: May 28, 2009
Last Updated: June 29, 2012
Health Authority: Turkey: Ministry of Health
Turkey: Ethics Committee

Keywords provided by Novartis:
Osteoporosis
Bone Mineral Density
Biomarkers

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
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 May 21, 2013