45
Participants
Start Date
June 28, 2022
Primary Completion Date
December 19, 2024
Study Completion Date
December 19, 2024
Follow-up of patients with postmenopausal osteoporosis, with or without fractures, requiring initiation of injectable bisphosphonate therapy as part of their usual care
"* Inclusion medical consultation~* Inclusion clinical examination~* Calculation of Kauppila score at one year~* Imaging procedures (DXA) at 1 year~* Magnesium dosage: Visit 1: Day 0 and Visit 3: Day 0+1 year~* Samples for biological collection and microbiota analysis Visit 1: Day 0 and Visit 3: Day 0+1 year~* Genotyping in Visit 1: Day 0~* Serum CTX dosage in Visit 3: Day 0+1 year~* Cardiovascular investigations (FMD, RHI, FLD, PWV) in Visit 1: Day 0 and Visit 3: Day 0+1 year~* Exploration of sarcopenia (SARC-F, SPPB, muscle strength and body composition) in Visit 1: Day 0 and Visit 3: Day 0+1 year~* Exploration of pain (NPS, BPI, sensitivity/pain thresholds, CPM) in Visit 1: Day 0 and Visit 3: Day 0+1 year~* Quality of life component questionnaires (PSQI, HADs, SF-36) in Visit 1: Day 0 and Visit 3: Day 0+1 year~* Follow-up diary to be completed at months 1 and 12 of the study"
Follow-up of patients with postmenopausal osteoporosis, fractured or not, requiring initiation of injectable bisphosphonate therapy as part of care with magnesium supplementation
"* Inclusion medical consultation~* Inclusion clinical examination~* Calculation of Kauppila score at one year~* Imaging procedures (DXA) at 1 year~* Magnesium dosage: Visit 1: Day 0; Visit 2: Day 0+9 months and Visit 3: Day 0+1 year~* Samples for biological collection and microbiota analysis Visit 1: Day 0 and Visit 3: Day 0+1 year~* Genotyping in Visit 1: Day 0~* Serum CTX dosage in Visit 3: Day 0+1 year~* Cardiovascular investigations (FMD, RHI, FLD, PWV) in Visit 1: Day 0 and Visit 3: Day 0+1 year~* Exploration of sarcopenia (SARC-F, SPPB, muscle strength and body composition) in Visit 1: Day 0 and Visit 3: Day 0+1 year~* Exploration of pain (NPS, BPI, sensitivity/pain thresholds, CPM) in Visit 1: Day 0 and Visit 3: Day 0+1 year~* Quality of life component questionnaires (PSQI, HADs, SF-36) in Visit 1: Day 0 and Visit 3: Day 0+1 year~* Magnesium intake for 1 period of 3 months~* Phone call~* Follow-up diary to be completed at months 1, 10, 11 and 12 of the study"
CHU clermont-ferrand, Clermont-Ferrand
University Hospital, Clermont-Ferrand
OTHER