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Completed

NCT Number: NCT00909961

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 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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigational site, Ankara, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

  1. Efficacy - BMD

    Time frame: 1 year

Secondary outcomes

  1. Efficacy - Biochemical markers

    Time frame: 6 months

  2. Safety - Rate of adverse events and serious adverse events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 29, 2009
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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