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MAGnesium Effect With ANtiosteoporotic Drugs

NCT05328154 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-12-27

No results posted yet for this study

Summary

Randomized pilot clinical trial to demonstrate superiority of bisphosphonate-magnesium combination over bisphosphonates alone in postmenopausal osteoporosis in slowing bone remodeling as assessed by C-terminal telopeptide of bone collagen type 1 (CTX) dosage.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

OTHER

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

DRUG

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

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Marie-Eva PICKERING · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2024-12-19
Completion
2024-12-19

Countries

  • France

Study Locations

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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 NCT05328154 on ClinicalTrials.gov