Zoledronic Acid in Cystic Fibrosis (IZAC)

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01702415
First received: October 4, 2012
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    Bone density measure by DEXA


Secondary Outcome Measures:
  • Effect of zoledronic acid on the number of bone fractures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Bone fractures


Other Outcome Measures:
  • Bone pain [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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
Placebo
Experimental: Zoledronic acid
Active IMP
Drug: Zoledronic acid
Single dose, intravenous solution 5mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702415

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

No publications provided

Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01702415     History of Changes
Other Study ID Numbers: P01612
Study First Received: October 4, 2012
Last Updated: September 23, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014