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Completed

NCT Number: NCT02271204

Observational Study of iv Ibandronate in Women With Postmenopausal Osteoporosis

This observational study assess the safety of intravenous Ibandronate (Bonviva) intermittent administration in patients with postmenopausal osteoporosis and the efficacy of IV Ibandronate (Bonviva treatment through relative lumbar spine and hip bone mineral densitometry form baseline at year 1)

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients had post menopausal osteoporosis
  • Patients had no contraindication for bisphosphonates
  • Patients had been naive for ibandronate therapy
  • Patients who have signed informed consent and are willing to share their data for data analysis

Exclusion criteria

  • Is not Ibandronate naïve
  • Hypersensitivity to any component of the bisphosphonates Ibandronate;
  • Administration of any investigational drug within 30 days preceding the first dose of the study drug.

Treatment and study plan

Ibandronic acid

Drug

As prescribed by physician

Other names: Bonviva

Primary outcomes

  1. Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of intravenous Ibandronate intermittent administration in patients with postmenopausal osteoporosis

    Time frame: end of observation 12 months

Sponsors and collaborators

Lead sponsor

Clinic of Endocrinology and Metabolic Disorders, Macedonia

Other

Collaborators

  • Clinic for Orthopedic Surgery, Skopje
  • General Hospital, Kumanovo
  • General Hospital, Struga
  • Medical Faculty, Institute for Epidemiology and Biostatistics, Skopje

Registry information

Official study title

Post Authorization Safety Study of iv Ibandronate (Bonviva) in Postmenopausal Osteoporosis, Observational, Non-interventional Open Label Trial

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Oct 22, 2014
Registry last updated
Oct 22, 2014

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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