Zoledronic Acid in Cystic Fibrosis

Phase 4

Withdrawn

• Conditions: Cystic Fibrosis
• Interventions: Drug: Placebo; Drug: Zoledronic acid

• Registration Number: NCT01702415
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-08
• Study Start: 2013-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-21
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Zoledronic acid	Zoledronic acid	Active IMP

Primary Outcome Measures

Name	Time	Method
Bone density	12 months	Bone density measure by DEXA

Secondary Outcome Measures

Name	Time	Method
Effect of zoledronic acid on the number of bone fractures	12 months	Bone fractures

Trial Locations

Locations (1)

Papworth Hospital NHS Foundation Trust; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom