OsteoporosisPhase 4NCT00491920
High Dosage Vitamin D and Osteoporosis
A Phase 4 study testing cholecalciferol (Vitamin D3) in people with Osteoporosis and Osteopenia, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a randomized double-blind trial. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- cholecalciferol (Vitamin D3)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 297 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2007to Feb 2010
- Phase
- Phase 4
- 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 50 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- bone mineral density in L2-4 or mean total hip with T-score <= -2.0
Who cannot join
- current use of bisphosphonates, PTH-analogs, estrogen, SERM, p.o. steroids or use of any of these agents last year
- serum creatinin >110 umol/L
- systolic blood pressure >175 mmHg or diastolic blod pressure >105
- serious disease (heart failure, angina pectoris, myocardial infarction, diabetes, mental reduction, granulomatous disease like sarcoidosis, cancer)
- kidney stone
- serum calcium > 2.55 mmol/L
- suspect primary hyperparathyroidism with serum calcium >2.50 mmol/L combined with PTH > 5.0 mmol/L or serum calcium > 2.45 mmol/L combined with PTH >= 7.0 pmol/L
Trial locations and contacts
1 site in 1 country.
Norway1 site
Medical Dpt. B, University Hospital of Northern Norway
Tromsø, 9012
About this study
Official title: High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women
Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women with T-score <= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week, while the other half will have placebo. The study period is one year.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- cholecalciferol (Vitamin D3), placebo
- Keywords
- osteoporosis, bone mineral density, vitamin D
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferol (Vitamin D3)Drug
20 000 Iu x2/week
+ calcium 500 mg/cholecalciferol 400 IU x2/d
placeboDrug
Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in bone mineral density in columna and total hip.
Measured: One year
Secondary outcomes (12)
Muscle strength (hand grip strength and knee extension)
Measured: One year
balance (tandem test)
Measured: One year
body composition (Dexa)
Measured: One year
inflammation markers
Measured: One year
calcium and vitamin D metabolism
Measured: One year
blood lipids
Measured: One year
renal function
Measured: One year
telomere length
Measured: one year
perception of own health
Measured: one year
Urinary tract symptoms
Measured: one year
effects of polymorphisms in VDR on the other endpoints
Measured: one year
side effects
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startFeb 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Norske Kvinners Sanitetsforening Troms
- Responsible party
- Sponsor
- Investigators
- Rolf Jorde, Ph.D, M.D, Principal investigator, Medical Dpt, University Hospital of Northern Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491920
- Sponsor's protocol ID
- 2006-003186-14
- Status last verified
- Nov 2011
- First submitted
- 25 Jun 2007
- Last updated
- 3 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00491920
- Acronym / sponsor ID
- 2006-003186-14
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- osteoporosis, bone mineral density, vitamin D
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Norske Kvinners Sanitetsforening Troms
- Study start
- Feb 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 26 Jun 2007 (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.
Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women with T-score <= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week, while the other half will have placebo. The study period is one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- bone mineral density in L2-4 or mean total hip with T-score <= -2.0
Key exclusion criteria (7 listed)
- current use of bisphosphonates, PTH-analogs, estrogen, SERM, p.o. steroids or use of any of these agents last year
- serum creatinin >110 umol/L
- systolic blood pressure >175 mmHg or diastolic blod pressure >105
- serious disease (heart failure, angina pectoris, myocardial infarction, diabetes, mental reduction, granulomatous disease like sarcoidosis, cancer)
- kidney stone
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 |
|---|---|---|
| cholecalciferol (Vitamin D3)20 000 Iu x2/week + calcium 500 mg/cholecalciferol 400 IU x2/d | Drug | – |
| placeboCalcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w | Drug | – |
Primary outcome
changes in bone mineral density in columna and total hip.
Time frame: One year
12 secondary outcomes
Muscle strength (hand grip strength and knee extension)
Time frame: One year
balance (tandem test)
Time frame: One year
body composition (Dexa)
Time frame: One year
inflammation markers
Time frame: One year
calcium and vitamin D metabolism
Time frame: One year
blood lipids
Time frame: One year
renal function
Time frame: One year
telomere length
Time frame: one year
perception of own health
Time frame: one year
Urinary tract symptoms
Time frame: one year
effects of polymorphisms in VDR on the other endpoints
Time frame: one year
side effects
Time frame: one year
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 3 Nov 2011.
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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.
Rolf Jorde, Ph.D, M.D principal investigator
Medical Dpt, University Hospital of Northern Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cholecalciferol (Vitamin D3) in people with Osteoporosis and Osteopenia, run by University Hospital of North Norway at 1 site in Norway.
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 7 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 3 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
changes in bone mineral density in columna and total hip. (time frame: One year). 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 3 Nov 2011.