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Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis

NCT03401060 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-31

No results posted yet for this study

Summary

The study is looking at the efficacy of subcutaneously administrated denosumab 60 mg every 6 months versus placebo after 3 years, by analyze of lumbar spine bone mineral density (BMD) in systemic mastocytosis.

Investigators hypothesize that use of denosumab subcutaneously in patients with osteoporosis related to systemic mastocytosis is effective and safe to improve bone mineral density and prevent new bone events, based on targeted specific RANKL secretion by mast cells and short half-life of denosumab.

Conditions

Interventions

DRUG

Denosumab

Each subcutaneous injection will occur every 6 months during 3 years for a total of 7 injections

DRUG

Placebo

Each subcutaneous injection will occur every 6 months during 3 years for a total of 7 injections

Sponsors & Collaborators

  • CEREMAST

    collaborator UNKNOWN

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Olivier Hermine, MD · Assistance Publique - Hôpitaux de Paris

  • Laurent FRENZEL, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2024-03-11
Completion
2024-03-11

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03401060 on ClinicalTrials.gov