High Dosage Vitamin D and Osteoporosis

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491920
• Other study ID #: 2006-003186-14
• Status: Completed
• Phase: Phase 4
• First received: June 25, 2007
• Last updated: November 2, 2011
• Start date: February 2007
• Est. completion date: February 2010

Study information

• Verified date: November 2011
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

Intervention

Drug:
• cholecalciferol (Vitamin D3)
20 000 Iu x2/week + calcium 500 mg/cholecalciferol 400 IU x2/d
• placebo
Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w

Locations

Country	Name	City	State
Norway	Medical Dpt. B, University Hospital of Northern Norway	Tromsø

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	Norske Kvinners Sanitetsforening Troms

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in bone mineral density in columna and total hip.		One year	No
Secondary	Muscle strength (hand grip strength and knee extension)		One year	No
Secondary	balance (tandem test)		One year	No
Secondary	body composition (Dexa)		One year	No
Secondary	inflammation markers		One year	No
Secondary	calcium and vitamin D metabolism		One year	Yes
Secondary	blood lipids		One year	No
Secondary	renal function		One year	Yes
Secondary	telomere length		one year	No
Secondary	perception of own health		one year	No
Secondary	Urinary tract symptoms		one year	No
Secondary	effects of polymorphisms in VDR on the other endpoints		one year	No
Secondary	side effects		one year	Yes