Phase 4 Osteoporosis Trial, Recruiting NCT05704036 Sponsor: Johns Hopkins University Condition: Osteoporosis
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Phase 4 Osteoporosis Trial, Recruiting

NCT05704036
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Main Study:

  • You have been diagnosed with cystic fibrosis (CF)
  • You are female and have had at least one menstrual period
  • You are willing to stay on the same type of estrogen supplement (or none at all) for the whole study

Feasibility Sub-Study (in addition to the above):

  • You are under 35 years old
  • It has been at least 2 years since your first menstrual period
  • You have symptoms of low estrogen and/or a blood test showing low estrogen levels

Who may not be able to join:

Main Study:

  • You are currently taking medication for osteoporosis (such as bisphosphonates, teriparatide, or denosumab)
  • You have a condition known to cause bone loss, such as currently breastfeeding
  • You are pregnant or planning to become pregnant
  • Your CF care team or the study team feels it would not be appropriate for you to take part
  • You are not able to give your own consent to participate

Feasibility Sub-Study (in addition to the above):

  • You have a medical reason why you cannot use estrogen patches on your skin (confirm with trial site)
  • You are currently taking estrogen in any form, such as the combined contraceptive pill
  • You have previously had a lung or liver transplant
  • You regularly take steroid tablets (such as prednisone) long-term
  • You have severely low vitamin D levels based on a blood test
  • You have a history of blood clots, are not able to move around much, have certain types of medical lines in place, or have a known condition that increases your risk of clotting
  • Your first study visit would be between 1 and 8 weeks after starting a CFTR modulator medication (a specific type of CF treatment)
  • You are currently having a lung flare-up (pulmonary exacerbation)
  • You have taken antibiotics for a lung flare-up in the past 4 weeks
  • You are unwilling or unable to use a non-estrogen form of contraception (such as condoms, abstinence, or a progesterone-only method)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Malinda Wu, MD, MSc, Johns Hopkins University

Phone: 410-929-3056

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
2 May 2023
Est. completion
1 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in lumbar spine bone mineral density assessed by dual-energy x-ray absorptiometry (DXA)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov