postmenopausal osteoporosis
Conditions
Interventions
Trade Name: MAG 2 100 mg
Product Name: MAG 2 100mg
Pharmaceutical Form: Tablet
Sponsors
University Hospital of Clermont-Ferrand
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Woman aged 50 or over, suffering from postmenopausal osteoporosis, fracture or not, requiring the initiation of treatment with injectable bisphosphonates as part of the care. - Able to give informed consent to participate in research. - Affiliation to a French Social Sregimen Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: - Initial densitometry more than a year old. - Patient receiving a treatment or food supplement containing magnesium. - Contraindication to the administration of Mg: hypersensitivity to magnesium carbonate or to any of the excipients. - Patient with magnesium> 1.07 mmol / l, - Patient with chronic renal failure, defined by a glomerular filtration rate <30 mL.min – 1 estimated by CKD-EPI - Patient with a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test. - Patient under legal protection or deprived of liberty. - Refusal of participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this randomized study is to demonstrate a superiority of the bisphosphonates-magnesium combination compared to bisphosphonates alone, in postmenopausal osteoporosis, on the reduction of bone remodeling, estimated by the dosage of C-telopeptide of type I collagen (CTX-I) ;Secondary Objective: 1 / Study the evolution of other biological markers of bone remodeling (by creating a biobank) and bone densitometry on the following sites: spine, femoral neck, total femur, 2 / Study the evolution of cardiovascular parameters, 3 / Study the evolution of sarcopenia, 4 / Study the evolution of quality of life and pain, 4 / Study the genetic predispositions of osteoporosis including the confirmation of known genetic markers and the potential identification of new genetic variants involved (by creating a biobank), 6 / Study the epigenetic biomarkers of the population of patients suffering from osteoporosis (by creating a biobank), 7 / Study the role of the microbiota in patients suffering from osteoporosis (by creating a biobank), 8 / The occurrence of side effects.;Primary end point(s): The primary endpoint is the change in CTX (C-telopeptide of type I collagen) after one year, defined as the difference [after - before], related to the basal value.;Timepoint(s) of evaluation of this end point: Baseline (Visit 1) and at one year (Visit 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 / Evaluation of certain parameters indicative of bone remodeling by blood sample 2/ Magnesemia by blood sample 3/ Evaluation of bone densitometric parameters at one year 4 / Evaluation of parameters indicative of cardiovascular risk by FMD/FLD/RHI 5 / Evaluation of the indicator parameters of Sarcopenia by SARC-F and SPPB questionnaires, measure of muscular force by a dynamometre and body composition by DXA 6/Evaluation of pain by BPI questionnaire, numerical pain rating scale, measure of Conditioned pain modulation (CPM) paradigms by Pathway medoc and measure of the sensitivity and pain perception threshold induced by a thermal stimulus (hot and cold) at the Pathway - Médoc® 7 / Evaluation of the indicators of quality of life by different questionnaires: sleep questionnaire (PSQI), anxiety and depression scale (HAD), Short-Form 36 health survey (SF-36) 8 / Distribution of gene polymorphisms by OpenArray technology by blood sample 9 / MicroRNA analysis using OpenArray technology by blood sample 10/ Study of the microbiota by blood collection;Timepoint(s) of evaluation of this end point: 1 / Evaluation of certain parameters indicative of bone remodeling by blood sample: visite 1 (baseline) and viist 3 (at one year) 2/ Magnesemia: visit 1 and 3 for the group "bisphosphonates alone" and Visits 1, 2 and 3 for the group "bisphosphonates associated with magnesium" 3/ Evaluation of bone densitometric parameters at one year (visit 3) 4 / Evaluation of parameters indicative of cardiovascular risk: visits 1 and 3 5 / Evaluation of of Sarcopenia: visits 1 and 3 6/Evaluation of pain: visits 1 and 3 7 / Evaluation of the indicators of quality of life: visits 1 and 3 8 / Distribution of gene polymorphisms: visit 1 (baseline) 9 / MicroRNA analysis using OpenArray technology: visits 1 and 3 10/ Study of the microbiota: visits 1 and 3 | — |
Countries
France
Contacts
Public ContactXavier BIJAYE
University Hospital of Clermont-Ferrand
Outcome results
None listed