Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Bone drug shows promise for rare mast cell disorder

NCT ID NCT03401060

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether denosumab, a drug given as a shot every 6 months, can improve bone density in people with osteoporosis caused by systemic mastocytosis. 24 adults with the condition took part. The goal was to see if the drug strengthens bones and prevents fractures better than a placebo.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

24 people

The number who actually took part.

Started

Mar 2018

Finished

Mar 2024

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.

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: * Male or female \>/= 18 years of age at time of informed consent * Willingness and ability to sign informed consent, comply with scheduled visits, treatment plan, laboratory tests and other study procedures. * Patient with Indolent systemic or cutaneous mastocytosis according to WHO criteria (Appendix 4) with any specific treatment including corticosteroid, chemotherapy and immunomodulating drugs. * Patient with: * osteoporosis defined as bone mineral density T score ≤ -2.5 at the lumbar spine, OR * osteopenia defined as BMD T-score \>-2,5 and ≤ -1 at the lumbar spine and low energy fracture (defined as fractures that are associated with decreased bone mineral density. Are excluded fractures of skull, face, mandible, metacarpals, fingers, or toes, pathologic fracture, and fracture that are associated with severe trauma). (in case of osteoarthritis at the lumbar spine, the T score at left femoral neck or total left hip can be used to define osteoporosis or osteopenia) Exclusion Criteria: * Patient with aggressive mastocytosis or/and Associated Hematologic Non-Mastocytosis Disease (AHNMD) * Patient with conditions that influence bone metabolism (primitive hyperparathyroidism, hyperaldosteronism, hypercorticism, etc …) * Patient treated with intravenous bisphosphonate within 1 year prior to enrolment or with any other antiosteoporotic treatment within 3 months before enrolment. (per os bisphosphonate, strontium ranelate) Calcium and vitamin supplementation will be accepted * Patient previously treated with denosumab * Patient with hypocalcemia and/or hypo25-hydroxyvitamin D level non substituted prior enrolment * Woman without contraceptive treatment if of childbearing age. * Pregnant or breastfeeding woman * Patient with contraindication to denosumab * Patient with medical, psychiatric or other conditions that may interfere with patient safety * Patient with dental problem that need any dental surgery within 6 months after enrolment. * Patient with clearance of creatinine less than 30 mL/min/1,73m2 (MDRD) or patient receiving dialysis

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Osteoporosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Mastocytosis, Systemic osteoporosis systemic mastocytosis

As listed by the trial registrant

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

Osteoporosis Systemic mastocytosis

Contacts and locations

Locations

  • Caen Hospital, Clinical haematology department

    Caen, 14033, France

  • Cochin Hospital, Rheumatology department

    Paris, 75014, France

  • Estaing Hospital, Cellular therapy and clinical haematology department

    Clermont-Ferrand, 63100, France

  • Jean Minjoz Hospital, Dermatology department

    Besançon, 25030, France

  • La Pitié-Salpêtrière Hospital, Internal medicine and clinical immunology department

    Paris, 75013, France

  • La Timone Hospital, Dermatology and cutaneous oncology department

    Marseille, 13385, France

  • Lapeyronie Hospital, Rheumatology and Immunology department

    Montpellier, 34295, France

  • Lille CHRU Hospital, Internal medicine and clinical immunology department

    Lille, 59037, France

  • Necker Hospital, Adult haematology department

    Paris, 75015, France

  • Strasbourg Hospital, Rheumatology department

    Strasbourg, 67098, France

  • Toulouse Hospital, Dermatology department

    Toulouse, 31060, France

More trials for these conditions

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