NCT02549521

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2014

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

November 22, 2014

Last Update Submit

September 14, 2015

Conditions

Unspecified Disorder of Bone Density and Structure

Keywords

calciummagnesiumvitamin Dbone turnover markers

Outcome Measures

Primary Outcomes (10)

  • Mg induced changes from day 0-28 on serum Ca and serum Mg, (mmol/L)

    28 days

  • Mg induced changes from day 0-28 on ratio U Ca/creatinin and ratio of Mg/creatinin, (umol/umol)

    28 days

  • Mg induced changes from day 0-28 on s-calcidiol (nmol/L)

    28 days

  • Mg induced changes from day 0-28 on s-calcitriol (pmol/L)

    28 days

  • Mg induced changes from day 0-28 on s-PTH ( pmol/L)

    28 days

  • Mg induced changes from day 0-28 on s-Bone ALP (u/L)

    28 days

  • Mg induced changes from day 0-28 on s-osteocalcin (nmol/L)

    28 days

  • Mg induced changes from day 0-28 on s- 1-CTP (ug/L)

    28 days

  • Mg induced changes from day 0-28 on U-PYD/creatinin (nmol/mmol)

    28 days

  • Mg induced changes from day 0-28 on U-1NTx (nmol/BCE/mmol/L creatinin)

    28 days

Study Arms (2)

Oral magnesium substitution

ACTIVE COMPARATOR

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

Dietary Supplement: Oral magnesium substitution

Magnesium + or Magnesium -

PLACEBO COMPARATOR

Placebo tablets without magnesium.

Dietary Supplement: Placebo tablets without magnesium

Interventions

Oral magnesium substitutionDIETARY_SUPPLEMENT

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.

Oral magnesium substitution
Placebo tablets without magnesiumDIETARY_SUPPLEMENT

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.

Magnesium + or Magnesium -

Eligibility Criteria

Age70 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Thomas Bøhmer, MD, PhD.

    University Hospital, Aker

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. em.

Study Record Dates

First Submitted

November 22, 2014

First Posted

September 15, 2015

Study Start

November 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

September 15, 2015

Record last verified: 2015-09