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CF Drug's hidden impact on bones and muscles revealed

NCT ID NCT04206436

Knowledge-focused Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how CFTR modulators, a type of cystic fibrosis treatment, affect bone strength and muscle mass in adults with CF. Researchers will measure changes in bone density and lean body mass over 12 to 24 months. The goal is to understand whether these treatments help or harm bone and muscle health. About 63 adults with confirmed CF are taking part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

63 people

The number who actually took part.

Started

Dec 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Enrollment will target groups that are frequency matched for age (decade), race, sex, pancreatic insufficiency and glucocorticoid usage (inhaled or systemic as both have skeletal effects in some studies) to control for these factors influencing relevant bone and muscle outcomes. (see statistical description). The study will enroll up to 30 subjects in each group, expecting up to 25% dropout.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Bone Diseases, Metabolic cystic fibrosis muscular atrophy osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bone loss Cystic fibrosis Muscle loss

Contacts and locations

Locations

  • Indiana University

    Indianapolis, Indiana, 46202-5149, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.