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Mg Induced Changes From Day 0 to Day 28 on Serum and Urine Bone Metabolic Parameters in 70 y Old Females (no 50). (parathormon)

Primary Purpose

Unspecified Disorder of Bone Density and Structure

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Oral magnesium substitution
Placebo tablets without magnesium
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Unspecified Disorder of Bone Density and Structure focused on measuring calcium, magnesium, vitamin D, bone turnover markers

Eligibility Criteria

70 Years - 70 Years (Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Homeliving healthy female volunteers aged 70 years old were recruited by phone.

Exclusion Criteria:

Persons who had used:

  • biphosphonates,
  • oestrogens,
  • glucocortocoids,
  • antiepileptic drugs,
  • diuretics,
  • immunmodulating agents,
  • prolonged usage of heparin.
  • patients with possible secondary osteoporosis and
  • diagnosis as:

    • inflammatory bowel disease,
    • primary hyperthyroidisms,
    • chronic obstructive lung disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Oral magnesium substitution

    Magnesium + or Magnesium -

    Arm Description

    Daily 240 mg Magnesium Nycomed Pharma. Intervention day 0 - day 28.

    Placebo tablets without magnesium.

    Outcomes

    Primary Outcome Measures

    Mg induced changes from day 0-28 on serum Ca and serum Mg, (mmol/L)
    Mg induced changes from day 0-28 on ratio U Ca/creatinin and ratio of Mg/creatinin, (umol/umol)
    Mg induced changes from day 0-28 on s-calcidiol (nmol/L)
    Mg induced changes from day 0-28 on s-calcitriol (pmol/L)
    Mg induced changes from day 0-28 on s-PTH ( pmol/L)
    Mg induced changes from day 0-28 on s-Bone ALP (u/L)
    Mg induced changes from day 0-28 on s-osteocalcin (nmol/L)
    Mg induced changes from day 0-28 on s- 1-CTP (ug/L)
    Mg induced changes from day 0-28 on U-PYD/creatinin (nmol/mmol)
    Mg induced changes from day 0-28 on U-1NTx (nmol/BCE/mmol/L creatinin)

    Secondary Outcome Measures

    Full Information

    First Posted
    November 22, 2014
    Last Updated
    September 14, 2015
    Sponsor
    Oslo University Hospital
    Collaborators
    Nycomed
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02549521
    Brief Title
    Mg Induced Changes From Day 0 to Day 28 on Serum and Urine Bone Metabolic Parameters in 70 y Old Females (no 50).
    Acronym
    parathormon
    Official Title
    Magnesium Supplementation in Elderly Females
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2006 (undefined)
    Primary Completion Date
    November 2007 (Actual)
    Study Completion Date
    November 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Oslo University Hospital
    Collaborators
    Nycomed

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Calcium and vitamin D substitution has for a long time been used to improve osteoporosis.The main storage place for magnesium is in the bone. Magnesium is direct under calcium in the periodic system making it possible to interact with the crystal structure. Some small studies have shown beneficial effects of magnesium substitution on osteoporosis. Evidence has shown improvement with calcium, alcohol, fruit and vegetable nutrients on bone loss. It has been uncertain however, which of these factors can contribute to such a change. The effect of magnesium substitution 240 mg daily as therefore studied in two parallel groups where both received calcium carbonate 1000 mg/day and cholecalciferol 10 ug/day, one got placebo and the other received magnesium. This was studied on various expressions for bone metabolism after zero, seven and 28 days in elderly females aged 70 years old.
    Detailed Description
    Elderly 70 year old ladies who had been to an outpatient X-ray investigation were invited to participate in this study. They were all healthy without any signs of osteoporosis, or fractures.They were stimulated to participate by having done bone density measurements free. Patients who had used biphosphonates, oestrogens, glucocorticoids , diuretics, immunomodulating agents, or prolonged use of heparin were excluded. Patients with possible secondary osteoporosis due to primary hyperthyroidism or chronic lung disease were also excluded. The participants were randomized into placebo or Mg-treatment groups. They were seen by the dietician, and blood and urine samples were taken at day 0, 7 and 28 at the same time these days. Medicine was prepacked for intake twice daily. They received medicine for 30 days and should only take for 28 days. The number of tablets which should be left was controlled the last day. The participants were informed about the results of the bone density measurements taken the first and the last day. All the patient contacts were undertaken by the same dietician.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unspecified Disorder of Bone Density and Structure
    Keywords
    calcium, magnesium, vitamin D, bone turnover markers

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral magnesium substitution
    Arm Type
    Active Comparator
    Arm Description
    Daily 240 mg Magnesium Nycomed Pharma. Intervention day 0 - day 28.
    Arm Title
    Magnesium + or Magnesium -
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo tablets without magnesium.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Oral magnesium substitution
    Intervention Description
    The elderly was given tablets two times daily with calsium and vitamin D. They were further given magnesium tablets 120 mg two times daily for 28 days.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo tablets without magnesium
    Intervention Description
    The elderly was given tablets two times daily with calsium and vitamin D. They were further given placebo without magnesium two times daily for 28 days.
    Primary Outcome Measure Information:
    Title
    Mg induced changes from day 0-28 on serum Ca and serum Mg, (mmol/L)
    Time Frame
    28 days
    Title
    Mg induced changes from day 0-28 on ratio U Ca/creatinin and ratio of Mg/creatinin, (umol/umol)
    Time Frame
    28 days
    Title
    Mg induced changes from day 0-28 on s-calcidiol (nmol/L)
    Time Frame
    28 days
    Title
    Mg induced changes from day 0-28 on s-calcitriol (pmol/L)
    Time Frame
    28 days
    Title
    Mg induced changes from day 0-28 on s-PTH ( pmol/L)
    Time Frame
    28 days
    Title
    Mg induced changes from day 0-28 on s-Bone ALP (u/L)
    Time Frame
    28 days
    Title
    Mg induced changes from day 0-28 on s-osteocalcin (nmol/L)
    Time Frame
    28 days
    Title
    Mg induced changes from day 0-28 on s- 1-CTP (ug/L)
    Time Frame
    28 days
    Title
    Mg induced changes from day 0-28 on U-PYD/creatinin (nmol/mmol)
    Time Frame
    28 days
    Title
    Mg induced changes from day 0-28 on U-1NTx (nmol/BCE/mmol/L creatinin)
    Time Frame
    28 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    70 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Homeliving healthy female volunteers aged 70 years old were recruited by phone. Exclusion Criteria: Persons who had used: biphosphonates, oestrogens, glucocortocoids, antiepileptic drugs, diuretics, immunmodulating agents, prolonged usage of heparin. patients with possible secondary osteoporosis and diagnosis as: inflammatory bowel disease, primary hyperthyroidisms, chronic obstructive lung disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas Bøhmer, MD, PhD.
    Organizational Affiliation
    University Hospital, Aker
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Mg Induced Changes From Day 0 to Day 28 on Serum and Urine Bone Metabolic Parameters in 70 y Old Females (no 50).

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