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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)

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ClinicalTrials.gov Identifier: NCT02549521
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : September 15, 2015
Sponsor:
Collaborator:
Nycomed
Information provided by (Responsible Party):
Thomas Bøhmer, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Unspecified Disorder of Bone Density and Structure Dietary Supplement: Oral magnesium substitution Dietary Supplement: Placebo tablets without magnesium Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Magnesium Supplementation in Elderly Females
Study Start Date : November 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

Arm Intervention/treatment
Active Comparator: Oral magnesium substitution
Daily 240 mg Magnesium Nycomed Pharma. Intervention day 0 - day 28.
Dietary Supplement: Oral magnesium substitution
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.

Placebo Comparator: Magnesium + or Magnesium -
Placebo tablets without magnesium.
Dietary Supplement: Placebo tablets without magnesium
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 Measures :
  1. Mg induced changes from day 0-28 on serum Ca and serum Mg, (mmol/L) [ Time Frame: 28 days ]
  2. Mg induced changes from day 0-28 on ratio U Ca/creatinin and ratio of Mg/creatinin, (umol/umol) [ Time Frame: 28 days ]
  3. Mg induced changes from day 0-28 on s-calcidiol (nmol/L) [ Time Frame: 28 days ]
  4. Mg induced changes from day 0-28 on s-calcitriol (pmol/L) [ Time Frame: 28 days ]
  5. Mg induced changes from day 0-28 on s-PTH ( pmol/L) [ Time Frame: 28 days ]
  6. Mg induced changes from day 0-28 on s-Bone ALP (u/L) [ Time Frame: 28 days ]
  7. Mg induced changes from day 0-28 on s-osteocalcin (nmol/L) [ Time Frame: 28 days ]
  8. Mg induced changes from day 0-28 on s- 1-CTP (ug/L) [ Time Frame: 28 days ]
  9. Mg induced changes from day 0-28 on U-PYD/creatinin (nmol/mmol) [ Time Frame: 28 days ]
  10. Mg induced changes from day 0-28 on U-1NTx (nmol/BCE/mmol/L creatinin) [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 70 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549521


Sponsors and Collaborators
Oslo University Hospital
Nycomed
Investigators
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Principal Investigator: Thomas Bøhmer, MD, PhD. University Hospital, Aker
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Responsible Party: Thomas Bøhmer, Prof. em., Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02549521    
Other Study ID Numbers: Nycomed 06.09.05
Nycomed contract 06.09.05 ( Other Grant/Funding Number: Nycomed )
Etical commitee, 548-05-99010 ( Other Identifier: REK )
Data inspectorate 13433 ( Registry Identifier: Datatilsynet )
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015
Keywords provided by Thomas Bøhmer, Oslo University Hospital:
calcium
magnesium
vitamin D
bone turnover markers
Additional relevant MeSH terms:
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Bone Diseases
Musculoskeletal Diseases