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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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: May 28, 2009
Last updated: March 17, 2017
Last verified: March 2017
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: Intervention Model: Single Group Assignment
Masking: None (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:

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

Primary Outcome Measures:
  • Efficacy - BMD [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Efficacy - Biochemical markers [ Time Frame: 6 months ]
  • Safety - Rate of adverse events and serious adverse events [ Time Frame: 6 months ]

Enrollment: 118
Study Start Date: November 2009
Study Completion Date: December 16, 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoledronic acid Drug: Zoledronic acid


Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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 identifier: NCT00909961

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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00909961     History of Changes
Other Study ID Numbers: CZOL446HTR04
Study First Received: May 28, 2009
Last Updated: March 17, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Bone Mineral Density

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on September 20, 2017