High Dosage Vitamin D and Osteoporosis
High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women
1 other identifier
interventional
297
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2007
Typical duration for phase_4
1 active site
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
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 25, 2007
CompletedFirst Posted
Study publicly available on registry
June 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedNovember 3, 2011
November 1, 2011
3 years
June 25, 2007
November 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes in bone mineral density in columna and total hip.
One year
Secondary Outcomes (12)
Muscle strength (hand grip strength and knee extension)
One year
balance (tandem test)
One year
body composition (Dexa)
One year
inflammation markers
One year
calcium and vitamin D metabolism
One year
- +7 more secondary outcomes
Interventions
20 000 Iu x2/week \+ calcium 500 mg/cholecalciferol 400 IU x2/d
Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w
Eligibility Criteria
You may qualify if:
- bone mineral density in L2-4 or mean total hip with T-score \<= -2.0
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Dpt. B, University Hospital of Northern Norway
Tromsø, 9012, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rolf Jorde, Ph.D, M.D
Medical Dpt, University Hospital of Northern Norway
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2007
First Posted
June 26, 2007
Study Start
February 1, 2007
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
November 3, 2011
Record last verified: 2011-11