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

Unspecified Disorder of Bone Density and Structure Clinical Trial

— parathormon  

Official title:

Magnesium Supplementation in Elderly Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549521
• Other study ID #: Nycomed 06.09.05
• Secondary ID: Nycomed contract
• Status: Completed
• Phase: Phase 1
• First received: November 22, 2014
• Last updated: September 14, 2015
• Start date: November 2006
• Est. completion date: November 2007

Study information

• Verified date: September 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data ServicesNorway: Data Protection AuthorityNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 70 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bone Diseases
• Unspecified Disorder of Bone Density and Structure

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Nycomed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mg induced changes from day 0-28 on serum Ca and serum Mg, (mmol/L)		28 days	No
Primary	Mg induced changes from day 0-28 on ratio U Ca/creatinin and ratio of Mg/creatinin, (umol/umol)		28 days	Yes
Primary	Mg induced changes from day 0-28 on s-calcidiol (nmol/L)		28 days	No
Primary	Mg induced changes from day 0-28 on s-calcitriol (pmol/L)		28 days	No
Primary	Mg induced changes from day 0-28 on s-PTH ( pmol/L)		28 days	No
Primary	Mg induced changes from day 0-28 on s-Bone ALP (u/L)		28 days	No
Primary	Mg induced changes from day 0-28 on s-osteocalcin (nmol/L)		28 days	No
Primary	Mg induced changes from day 0-28 on s- 1-CTP (ug/L)		28 days	No
Primary	Mg induced changes from day 0-28 on U-PYD/creatinin (nmol/mmol)		28 days	No
Primary	Mg induced changes from day 0-28 on U-1NTx (nmol/BCE/mmol/L creatinin)		28 days	No