Unspecified Disorder of Bone Density and StructurePhase 1parathormonNCT02549521
Mg Induced Changes From Day 0 to Day 28 on Serum and Urine Bone Metabolic Parameters in 70 y Old Females (no 50).
A Phase 1 study testing Oral magnesium substitution in people with Unspecified Disorder of Bone Density and Structure, run by Oslo University Hospital.
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. Read more about this study
- Who is it for?
- Ages 70 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unspecified Disorder of Bone Density and Structure
- What is being tested?
- Oral magnesium substitution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Nov 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 70 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Homeliving healthy female volunteers aged 70 years old were recruited by phone.
Who cannot join
- Persons who had used:
- biphosphonates,
- oestrogens,
- glucocortocoids,
- antiepileptic drugs,
- diuretics,
Show all 13Show fewer
- immunmodulating agents,
- prolonged usage of heparin.
- patients with possible secondary osteoporosis and
- diagnosis as:
- inflammatory bowel disease,
- primary hyperthyroidisms,
- chronic obstructive lung disease
About this study
Official title: Magnesium Supplementation in Elderly Females
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.
Read the 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.
- Being tested
- Oral magnesium substitution, Placebo tablets without magnesium
- Keywords
- calcium, magnesium, vitamin D, bone turnover markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral magnesium substitution | Active comparator | Daily 240 mg Magnesium Nycomed Pharma. Intervention day 0 - day 28. Receives: Dietary Supplement: Oral magnesium substitution |
| Magnesium + or Magnesium - | Placebo comparator | Placebo tablets without magnesium. Receives: Dietary Supplement: Placebo tablets without magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mg induced changes from day 0-28 on serum Ca and serum Mg, (mmol/L)
Measured: 28 days
Mg induced changes from day 0-28 on ratio U Ca/creatinin and ratio of Mg/creatinin, (umol/umol)
Measured: 28 days
Mg induced changes from day 0-28 on s-calcidiol (nmol/L)
Measured: 28 days
Mg induced changes from day 0-28 on s-calcitriol (pmol/L)
Measured: 28 days
Mg induced changes from day 0-28 on s-PTH ( pmol/L)
Measured: 28 days
Mg induced changes from day 0-28 on s-Bone ALP (u/L)
Measured: 28 days
Mg induced changes from day 0-28 on s-osteocalcin (nmol/L)
Measured: 28 days
Mg induced changes from day 0-28 on s- 1-CTP (ug/L)
Measured: 28 days
Mg induced changes from day 0-28 on U-PYD/creatinin (nmol/mmol)
Measured: 28 days
Mg induced changes from day 0-28 on U-1NTx (nmol/BCE/mmol/L creatinin)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startNov 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Disorder of Bone Density and StructureStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nycomed
- Responsible party
- Principal investigator, Thomas Bøhmer, Oslo University Hospital
- Investigators
- Thomas Bøhmer, MD, PhD., Principal investigator, University Hospital, Aker
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549521
- Sponsor's protocol ID
- Nycomed 06.09.05
- Other IDs
- Nycomed contract 06.09.05, Etical commitee, 548-05-99010, Data inspectorate 13433
- Acronym
- parathormon
- Status last verified
- Sep 2015
- First submitted
- 22 Nov 2014
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Supplementation in Elderly Females
- ClinicalTrials.gov ID
- NCT02549521
- Acronym / sponsor ID
- parathormon / Nycomed 06.09.05
- Keywords
- calcium, magnesium, vitamin D, bone turnover markers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Nycomed
- Study start
- Nov 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral magnesium substitution | Active comparator | Dietary Supplement: Oral magnesium substitutionDaily 240 mg Magnesium Nycomed Pharma. Intervention day 0 - day 28. |
| Magnesium + or Magnesium - | Placebo comparator | Dietary Supplement: Placebo tablets without magnesiumPlacebo tablets without magnesium. |
Who may qualify
- Ages
- 70 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Homeliving healthy female volunteers aged 70 years old were recruited by phone.
Key exclusion criteria (13 listed)
- biphosphonates,
- oestrogens,
- glucocortocoids,
- antiepileptic drugs,
- diuretics,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral magnesium substitutionThe 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. | Dietary supplement | Oral magnesium substitution |
| Placebo tablets without magnesiumThe 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. | Dietary supplement | Magnesium + or Magnesium - |
Primary outcome
Mg induced changes from day 0-28 on serum Ca and serum Mg, (mmol/L)
Time frame: 28 days
Mg induced changes from day 0-28 on ratio U Ca/creatinin and ratio of Mg/creatinin, (umol/umol)
Time frame: 28 days
Mg induced changes from day 0-28 on s-calcidiol (nmol/L)
Time frame: 28 days
Mg induced changes from day 0-28 on s-calcitriol (pmol/L)
Time frame: 28 days
Mg induced changes from day 0-28 on s-PTH ( pmol/L)
Time frame: 28 days
Mg induced changes from day 0-28 on s-Bone ALP (u/L)
Time frame: 28 days
Mg induced changes from day 0-28 on s-osteocalcin (nmol/L)
Time frame: 28 days
Mg induced changes from day 0-28 on s- 1-CTP (ug/L)
Time frame: 28 days
Mg induced changes from day 0-28 on U-PYD/creatinin (nmol/mmol)
Time frame: 28 days
Mg induced changes from day 0-28 on U-1NTx (nmol/BCE/mmol/L creatinin)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Bøhmer, MD, PhD. principal investigator
University Hospital, Aker
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral magnesium substitution in people with Unspecified Disorder of Bone Density and Structure, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mg induced changes from day 0-28 on serum Ca and serum Mg, (mmol/L) (time frame: 28 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2015.