Status:
COMPLETED
Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
CEREMAST
Conditions:
Osteoporosis
Systemic Mastocytosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 mast...
Detailed Description
Systemic mastocytosis (SM) represents a heterogenous group of disease characterized by abnormal proliferation of mast cells caused by activating mutations in c-Kit receptor; a tyrosine kinase family r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03401060
Start Date
March 5 2018
End Date
March 11 2024
Last Update
May 3 2024
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Jean Minjoz Hospital, Dermatology department
Besançon, France, 25030
2
Caen Hospital, Clinical haematology department
Caen, France, 14033
3
Estaing Hospital, Cellular therapy and clinical haematology department
Clermont-Ferrand, France, 63100
4
Lille CHRU Hospital, Internal medicine and clinical immunology department
Lille, France, 59037