High Dosage Vitamin D and Osteoporosis

High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00491920

Enrollment

297

Registered

2007-06-26

Start date

2007-02-28

Completion date

2010-02-28

Last updated

2011-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Osteopenia

Keywords

osteoporosis, bone mineral density, vitamin D

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.

Interventions

DRUGcholecalciferol (Vitamin D3)

20 000 Iu x2/week \+ calcium 500 mg/cholecalciferol 400 IU x2/d

DRUGplacebo

Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* bone mineral density in L2-4 or mean total hip with T-score \<= -2.0

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
changes in bone mineral density in columna and total hip.	One year

Secondary

Measure	Time frame
balance (tandem test)	One year
body composition (Dexa)	One year
inflammation markers	One year
calcium and vitamin D metabolism	One year
blood lipids	One year
Muscle strength (hand grip strength and knee extension)	One year
telomere length	one year
perception of own health	one year
Urinary tract symptoms	one year
effects of polymorphisms in VDR on the other endpoints	one year
side effects	one year
renal function	One year

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026