CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis (NCT04206436) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
United States63 participantsStarted 2019-12-18
Plain-language summary
Study is looking at the effects of cystic fibrosis treatment on bone muscle.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* documented, confirmed diagnosis of CF
* Age ≥18 years old
* \>21 days since the start of their last pulmonary exacerbation at the baseline visit
* Provide signed written informed consent to participate
Exclusion Criteria:
* • Estimated glomerular filtration rate (eGFR) \<30 ml/min/m2 using the CKD-EPI equation,
* Treatment with any osteoporosis medication within 6 months for oral agents or 1 year for intravenous or injectable agents (Subjects may participate if therapy stopped earlier than these time periods).
* Current treatment with growth hormone or IGF-1
* Currently pregnant or lactating or planning plan on becoming pregnant during the duration of the study.
* Life expectancy less than 12 months
* History of lung transplantation
* Conditions that in the opinion of the investigators would interfere with the ability to collect or interpret the data, or put the patient at higher safety risk from study procedures.
What they're measuring
1
Identify the effects of CFTR modulators on bone mineral density
Timeframe: 12 months
2
establish the effect of CFTR modulators on sarcopenia.