Zoledronic Acid in Cystic Fibrosis

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01702415

Acronym

IZAC

Enrollment

Registered

2012-10-08

Start date

2013-10-31

Completion date

2015-12-31

Last updated

2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis, Bone density

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.

Interventions

DRUGZoledronic acid

Single dose, intravenous solution 5mg

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Bone density	12 months	Bone density measure by DEXA

Secondary

Measure	Time frame	Description
Effect of zoledronic acid on the number of bone fractures	12 months	Bone fractures

Other

Measure	Time frame	Description
Bone pain	12 months	Frequency and severity of bone pain as a possible side effect of zoledronic acid

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026