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Zoledronic Acid in Cystic Fibrosis (IZAC)

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: NCT01702415
Recruitment Status : Withdrawn (Lack of funding)
First Posted : October 8, 2012
Last Update Posted : October 21, 2015
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

Brief Summary:

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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Zoledronic acid Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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.
Study Start Date : October 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Zoledronic acid
Active IMP
Drug: Zoledronic acid
Single dose, intravenous solution 5mg

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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): NCT01702415

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United Kingdom
Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Novartis Pharmaceuticals
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Principal Investigator: Charles Dr Haworth, FRCP Papworth Hospital NHS Foundation Trust
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Responsible Party: Papworth Hospital NHS Foundation Trust Identifier: NCT01702415    
Other Study ID Numbers: P01612
First Posted: October 8, 2012    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015
Keywords provided by Papworth Hospital NHS Foundation Trust:
Cystic fibrosis
Bone density
Additional relevant MeSH terms:
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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