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Zoledronic Acid in Cystic Fibrosis (IZAC)

This study has been withdrawn prior to enrollment.
(Lack of funding)
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust Identifier:
First received: October 4, 2012
Last updated: October 19, 2015
Last verified: October 2015

Null hypotheses: zoledronic acid does not improve bone density in cystic fibrosis.

Low bone mineral density (osteoporosis) is prevalent in adults with cystic fibrosis (CF); they have an increased rate of bone fractures in comparison to the general population. CF patients start to lose bone density in adolescence/early adulthood due to an imbalance in bone breakdown and formation. Predicted survival for patients with CF has increased from 16 years in 1970 to 36.5 years in 2009 which has resulted in an increase in comorbidities associated with increased longevity in CF e.g. decreased bone density. Oral and intravenous bisphophosphonates are known to increase bone density in CF; the current licensed oral preparations require daily or weekly dosing which are difficult to maintain. Zoledronate, which is licensed for use, is administered intravenously once a year which should be easier to administer. The current evidence relates to its use in other disease groups e.g. glucocorticoid induced osteoporosis and oncology. The purpose of this study is to ascertain its efficacy in cystic fibrosis.

Condition Intervention Phase
Cystic Fibrosis Drug: Zoledronic acid Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double Blind, Placebo Controlled Trial to Ascertain the Efficacy and Safety of Intravenous Zoledronic Acid in Adult Patients With Cystic Fibrosis.

Resource links provided by NLM:

Further study details as provided by Papworth Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Bone density [ Time Frame: 12 months ]
    Bone density measure by DEXA

Secondary Outcome Measures:
  • Effect of zoledronic acid on the number of bone fractures [ Time Frame: 12 months ]
    Bone fractures

Other Outcome Measures:
  • Bone pain [ Time Frame: 12 months ]
    Frequency and severity of bone pain as a possible side effect of zoledronic acid

Enrollment: 0
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Zoledronic acid
Active IMP
Drug: Zoledronic acid
Single dose, intravenous solution 5mg


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of cystic fibrosis
  • Aged at least 18 years
  • Bone mineral density score of -1.5 or less at lumbar spine or total hip
  • Able to give informed consent

Exclusion Criteria:

  • Previous solid organ transplant
  • on solid organ transplant waiting list
  • Long trem oral glucocorticosteroids
  • CRP >20mg on day of randomisation
  • Hypocalcaemia
  • Poor dental hygiene
  Contacts and Locations
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Please refer to this study by its identifier: NCT01702415

United Kingdom
Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Novartis Pharmaceuticals
Principal Investigator: Charles Dr Haworth, FRCP Papworth Hospital NHS Foundation Trust
  More Information

Responsible Party: Papworth Hospital NHS Foundation Trust Identifier: NCT01702415     History of Changes
Other Study ID Numbers: P01612
Study First Received: October 4, 2012
Last Updated: October 19, 2015

Keywords provided by Papworth Hospital NHS Foundation Trust:
Cystic fibrosis
Bone density

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on September 20, 2017