IZAC: Zoledronic Acid in Cystic Fibrosis

Sponsor

Papworth Hospital NHS Foundation Trust (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01702415

Collaborator

Novartis Pharmaceuticals (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Oct 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Placebo

Drug: Placebo

Experimental: Zoledronic acid

Active IMP

Drug: Zoledronic acid

Single dose, intravenous solution 5mg

Outcome Measures

Primary Outcome Measures

Bone density [12 months]
Bone density measure by DEXA

Secondary Outcome Measures

Effect of zoledronic acid on the number of bone fractures [12 months]
Bone fractures

Other Outcome Measures

Bone pain [12 months]
Frequency and severity of bone pain as a possible side effect of zoledronic acid

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Papworth Hospital NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT01702415

Other Study ID Numbers:

P01612

First Posted:

Oct 8, 2012

Last Update Posted:

Oct 21, 2015

Last Verified:

Oct 1, 2015

Keywords provided by Papworth Hospital NHS Foundation Trust

Cystic fibrosis

Bone density

Additional relevant MeSH terms:

Cystic Fibrosis

Fibrosis

Zoledronic Acid

Study Results

No Results Posted as of Oct 21, 2015