Osteoporosis Trial, Recruiting
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:
Group 1 (Mast Cell Activation) — People who meet the criteria for either of the following:
- People who have had a documented severe allergic reaction (anaphylaxis) to insect stings (such as bees or wasps) that affected the heart or blood circulation, OR a severe allergic reaction with no known cause that required a hospital visit, emergency room care, and/or an adrenaline injection and affected the heart or blood circulation.
- People who experience recurring episodes of symptoms affecting at least 2 body systems — such as the skin, breathing/nose/eyes, digestive system, or heart and circulation — without a known trigger, and who have shown some response to medication aimed at reducing mast cell activity, as determined by the study doctor.
Group 2 (Related Conditions) — People who have a confirmed diagnosis of one of the following:
- A connective tissue condition called hypermobile Ehlers-Danlos syndrome, or a documented history of a related condition called hypermobility spectrum disorder.
- A condition called postural orthostatic tachycardia syndrome (a heart rate disorder when standing), along with one or more symptoms affecting the body more broadly.
- Bone thinning (either osteoporosis or osteopenia) that was diagnosed at age 50 or younger.
Group 3 (Blood Conditions) — People who have a documented diagnosis of one of the following, confirmed using World Health Organization classification guidelines:
- A blood condition called chronic myelomonocytic leukemia, OR a related bone marrow condition classified as myelodysplastic syndrome/myeloproliferative neoplasm not otherwise specified.
Who may not be able to join:
- People who have previously been diagnosed with a specific type of mast cell condition involving a gene change known as a KIT mutation (monoclonal mast cell activation syndrome with KIT mutation).
- People whose mast cell condition affects only the skin, with no confirmed evidence of mast cell disease in the bone marrow.
- People who have been diagnosed with any form of systemic mastocytosis (a condition where mast cells build up in organs throughout the body).
- People who have been diagnosed with mast cell sarcoma (a rare and aggressive mast cell tumour).
- For Group 2 only: People whose bone thinning (osteopenia or osteoporosis) is already explained by a known genetic, hormonal, nutritional, or other medical condition.
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.
Contact this trial
Phone: +1-888-258-7768
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Proportion of Participants in Cohort 1 with KIT D816V Mutation in Peripheral Blood as Measured by Digital Droplet Polymerase Chain Reaction (ddPCR); Proportion of Participants in Cohort 1 with KIT D816V Mutation in Peripheral Blood as Measured by Ultra-sensitive KIT D816V by Rolling Circle Amplification (RCA) Assay
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.