MAGnesium Effect With ANtiosteoporotic Drugs

NCT05328154 | Completed Phase 2

• 2 other identifiers: AOI 2021 ME_PICKERING2021-005401-28
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Osteoporosis; Magnesium; CTX; Bone remodeling

Outcome Measures

Primary Outcomes (2)

• C-terminal telopeptides of collagen type 1 (CTX) dosage

  Evaluation of the CTX evolution after one year, defined as the difference \[after - before\], relative to the basal value (ng/ml). For this purpose, a blood sample will be taken using 5 mL dry tubes.

  Visit 0: Day 0-1 month

• C-terminal telopeptides of collagen type 1 (CTX) dosage

  Evaluation of the CTX evolution after one year, defined as the difference \[after - before\], relative to the basal value (ng/ml). For this purpose, a blood sample will be taken using 5 mL dry tubes.

  Visit 3: Day 0+1 year

Secondary Outcomes (58)

• N-terminal propeptide of procollagen type 1 (P1NP) dosage

  Visit 1: Day 0

• N-terminal propeptide of procollagen type 1 (P1NP) dosage

  Visit 3: Day 0+1 year

• Osteocalcin dosage

  Visit 1: Day 0

• Osteocalcin dosage

  Visit 3: Day 0+1 year

• Sclerostin dosage

  Visit 1: Day 0

Study Arms (2)

Bisphosphonates (zoledronic acid, Aclasta® 5 mg) alone

OTHER

Bisphosphonates are considered as the gold standard of treatment for osteoporosis. Zoledronic acid, Aclasta® 5 mg will be administered intravenously according to standard management criteria in order to obtain an homogeneous population.

Other: Follow-up of patients with postmenopausal osteoporosis, with or without fractures, requiring initiation of injectable bisphosphonate therapy as part of their usual care

bisphosphonates (zoledronic acid, Aclasta® 5 mg) associated with magnesium (MAG 2®, 100 mg)

ACTIVE COMPARATOR

In addition to bisphosphonates, patients in this group will take a 3-month treatment of magnesium (magnesium carbonate, MAG 2® 100 mg), 2 tablets of 100 mg/day, during the 3 months preceding the 1-year visit.

Drug: Follow-up of patients with postmenopausal osteoporosis, fractured or not, requiring initiation of injectable bisphosphonate therapy as part of care with magnesium supplementation

Interventions

Follow-up of patients with postmenopausal osteoporosis, with or without fractures, requiring initiation of injectable bisphosphonate therapy as part of their usual care OTHER

* 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

Bisphosphonates (zoledronic acid, Aclasta® 5 mg) alone

Follow-up of patients with postmenopausal osteoporosis, fractured or not, requiring initiation of injectable bisphosphonate therapy as part of care with magnesium supplementation DRUG

* 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

bisphosphonates (zoledronic acid, Aclasta® 5 mg) associated with magnesium (MAG 2®, 100 mg)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 50 years or older, with postmenopausal osteoporosis, fractured or not, requiring initiation of injectable bisphosphonate therapy as part of their care.
• Able to give informed consent to participate in the research.
• Affiliation to a Social Security system.

You may not qualify if:

• Initial densitometry more than one year old.
• Patient receiving a treatment or food supplement containing magnesium (Mg).
• Contra-indication to the administration of Mg: hypersensitivity to magnesium carbonate or to one of the excipients.
• Patients with a magnesium level \> 1.07 mmol/l.
• Patient with chronic renal failure, defined as creatinine clearance \< 35 mL/min estimated by Cockcroft-Gault or glomerular filtration rate \< 30 mL.min-1 estimated by CKD-EPI and taking into account which is more pejorative.
• Patient with a medical and/or surgical history deemed by the investigator or his representative to be incompatible with the trial.
• Patient under legal protection or deprived of liberty.
• Refusal to participate.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

Related Publications (1)

• Pickering ME, Morel V, Nicolas M, Duale C, Sortais E, Graven-Nielsen T, Pereira B, Pickering G. Quantitative sensory testing of pain in osteoporosis: a pilot randomized clinical trial with magnesium supplementation. Aging Clin Exp Res. 2026 Jan 21. doi: 10.1007/s40520-025-03317-9. Online ahead of print.

  PMID: 41566091 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

Nuclear Receptor Subfamily 4, Group A, Member 2

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Orphan Nuclear Receptors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cytoplasmic and Nuclear

Study Officials

• Marie-Eva PICKERING

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Following the inclusion visit, patients will be assigned to one of the two groups (bisphosphonates alone or bisphosphonate associated with magnesium). Treatment assignment will follow a predefined randomization list and will be performed by a Clinical Research Associate who is totally independent from the protocol. The randomization list and a copy will be edited and given to the Clermont-Ferrand University Hospital Pharmacy and to the Rheumatology Department of the Gabriel Montpied University Hospital.

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 14, 2022
• Study Start: June 28, 2022
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

FR (1)