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 range

18 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Identify the effects of CFTR modulators on bone mineral density

Timeframe: 12 months

establish the effect of CFTR modulators on sarcopenia.

Timeframe: 12 months

Trial details

NCT IDNCT04206436

SponsorIndiana University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Cystic Fibrosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.