Zoledronic Acid in Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 2 November 2015
• Main ID: NCT01702415
• Date of registration: 04/10/2012
• Prospective Registration: Yes
• Primary sponsor: Papworth Hospital NHS Foundation Trust
• Public title: Zoledronic Acid in Cystic Fibrosis IZAC
• Scientific title: Randomised, Double Blind, Placebo Controlled Trial to Ascertain the Efficacy and Safety of Intravenous Zoledronic Acid in Adult Patients With Cystic Fibrosis.
• Date of first enrolment: October 2013
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01702415
• 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
• Phase: Phase 4

Countries of recruitment

United Kingdom

Contacts

• Name: Charles Dr Haworth, FRCP
• Affiliation: Papworth Hospital NHS Foundation Trust

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Placebo

Drug: Zoledronic acid

Primary Outcome(s)

Bone density [Time Frame: 12 months]

Secondary Outcome(s)

Effect of zoledronic acid on the number of bone fractures [Time Frame: 12 months]

Secondary ID(s)

P01612

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis Pharmaceuticals