Cystic Fibrosis Clinical Trial
Official title:
Osteoporosis in Cystic Fibrosis: Study of Bone Mass and Bone Metabolism, and Prospective Randomized Therapeutic Trial.
Cystic fibrosis (CF) -- an autosomal recessive genetic disease affecting about 60,000
individuals worldwide, including about 3,800 in Italy -- is often associated with low bone
mineral mass. The current aggressive therapies have ensured a much longer survival of CF
patients but this has led to a higher frequency of osteoporosis and bone fractures, a
serious problem which not only affects quality of life, but also hinders further therapeutic
measures.
The aim of this study, conducted on a large group of children, adolescents and young adults
with CF, has been the evaluation of bone mass changes after 1 year of a simple treatment
with RDA-adjusted dietary calcium plus 25-OH vitamin D supplementation, and the feasibility
and efficacy of alendronate treatment (for another year) in patients not responding to
calcium + 25-OH vitamin D alone.
The study included 2 phases.
Phase 1 (1-year open-label observational study): following baseline evaluation, bone mass
changes have been studied with a simple therapy of adequate calcium intake and 25-OH vitamin
D supplements in all eligible subjects (N=171).
Phase 2 (1-year double-blind, randomized, placebo-controlled, parallel group study): the 128
subjects showing an insufficient response to calcium + 25-OH vitamin D alone (bone mass
increase <5%) at the end of Phase 1, were randomized into 2 groups and assigned to
alendronate treatment (N=65) or placebo (N=63) (in addition to calcium and 25-OH vitamin D
as during Phase 1).
The study has been carried out by the Coordinator's Institution (Istituto Auxologico
Italiano)in collaboration with most Regional Reference Centers for CF in Italy.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04696198 -
Thoracic Mobility in Cystic Fibrosis Care
|
N/A | |
Completed |
NCT00803205 -
Study of Ataluren (PTC124™) in Cystic Fibrosis
|
Phase 3 | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03601637 -
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
|
Phase 3 | |
Terminated |
NCT02769637 -
Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
|
||
Recruiting |
NCT06012084 -
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
|
N/A | |
Recruiting |
NCT06030206 -
Lung Transplant READY CF 2: A Multi-site RCT
|
N/A | |
Recruiting |
NCT06032273 -
Lung Transplant READY CF 2: CARING CF Ancillary RCT
|
N/A | |
Recruiting |
NCT05392855 -
Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)
|
N/A | |
Recruiting |
NCT06088485 -
The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
|
||
Recruiting |
NCT04056702 -
Impact of Triple Combination CFTR Therapy on Sinus Disease.
|
||
Recruiting |
NCT04039087 -
Sildenafil Exercise: Role of PDE5 Inhibition
|
Phase 2/Phase 3 | |
Completed |
NCT04038710 -
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
|
||
Completed |
NCT04058548 -
Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
|
N/A | |
Completed |
NCT03637504 -
Feasibility of a Mobile Medication Plan Application in CF Patient Care
|
N/A | |
Recruiting |
NCT03506061 -
Trikafta in Cystic Fibrosis Patients
|
Phase 2 | |
Completed |
NCT03566550 -
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
|
||
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
Recruiting |
NCT04010253 -
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
|
N/A |