Zoledronic Acid in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— IZAC  

Official title:

Randomised, Double Blind, Placebo Controlled Trial to Ascertain the Efficacy and Safety of Intravenous Zoledronic Acid in Adult Patients With Cystic Fibrosis.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01702415
• Other study ID #: P01612
• Status: Withdrawn
• Phase: Phase 4
• First received: October 4, 2012
• Last updated: October 19, 2015
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: Papworth Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Zoledronic acid
Single dose, intravenous solution 5mg
• Placebo

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital NHS Foundation Trust	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust	Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bone pain	Frequency and severity of bone pain as a possible side effect of zoledronic acid	12 months	Yes
Primary	Bone density	Bone density measure by DEXA	12 months	No
Secondary	Effect of zoledronic acid on the number of bone fractures	Bone fractures	12 months	No