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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

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. Identifier: NCT00909961
Recruitment Status : Completed
First Posted : May 29, 2009
Last Update Posted : March 21, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: Zoledronic acid Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: N/A
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
Study Start Date : November 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 16, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: Zoledronic acid Drug: Zoledronic acid

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older 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

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 identifier (NCT number): NCT00909961

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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00909961    
Other Study ID Numbers: CZOL446HTR04
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Bone Mineral Density
Additional relevant MeSH terms:
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Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs