OSTPRE-Fracture Prevention Study

Osteoporosis Clinical Trial

— OSTPRE-FPS  

Official title:

OSTPRE-FPS Prevention of Fractures and Falls in Postmenopausal Women With Calcium and Vitamin-D Supplementation - a Randomised Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592917
• Other study ID #: KUH5204512
• Secondary ID: 119/2001
• Status: Completed
• Phase: Phase 4
• First received: January 2, 2008
• Last updated: January 11, 2008
• Start date: August 2002
• Est. completion date: October 2007

Study information

• Verified date: January 2008
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Research Ethics Committee, Hospital District of Northern Savo, Finland:
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of calcium 1000 mg/d and vitamin-D3 800 IU/d divided in two daily doses on the incidence of falls and fractures, bone mineral density and bone metabolism in postmenopausal women 65-71 years of age.

Description:

In aging population osteoporotic fractures in postmenopausal women are a growing problem and a cause of remarkable morbidity, individual suffering and costs. The effect of calcium and vitamin-D in fracture prevention have been tested in elderly patients mostly over 70-75 years of age and results with low dose intervention have been controversial. The aim of this study is to determine the effects of calcium (1000 mg/d) and vitamin-D (800 IU/d) in 65-71 year-old postmenopausal women in a clinical trial on two levels: a) a randomized postal interview trial (n=3432) and b) a randomized clinical trial (n=606). 5407 women of the OSTPRE-cohort received a postal enquiry with questions of health related issues and willingness to participate a calcium and vitamin-D survey. 4706 enquiries were returned. 3432 eligible women were randomised to the active treatment group (n=1718) to receive the intervention and control group (n=1714), that did not receive placebo, they were told to go on as before in terms of calcium or vitamin-D substitution. On the level of the interview trial end point variables, falls and fractures, are collected by telephone interviews annually and on the level of the clinical trial every four months. In clinically examined subset of 606 subjects axial and heel bone mineral density (BMD), heel quantitative ultrasound (QUS) measurement, anthropometric measurements, a comprehensive set of clinical (muscle strength, balance, functional capacity) and laboratory tests (serum calcium, phosphate, AFOS, creatinine, cholesterol, triglycerides, complete blood count, 25-OH-D-vitamin, PTH, osteocalcin and Trap5B and reserve, serum and urine samples) will be performed and food diary will be obtained at baseline and after 3 years follow-up and baseline blood samples will be taken for DNA-analyses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3432
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Alive member of the original population based sample (n=14220) of Kuopio Osteoporosis Risk factor and Prevention Study

• Age 65 years or older on 30.11.2002

• Not participating any previous BMD-measurement in OSTPRE

• Living in the province of Kuopio

• Adequately filled baseline enquiry

• Willing to participate calcium and vitamin-D -survey

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fractures
• Fractures, Bone
• Osteoporosis

Intervention

Dietary Supplement:
• calcium carbonate and cholecalciferol
one tablet (calcium carbonate resembling 500 mg of calcium and 400 IU or 5 micrograms of vitamin-D3, cholecalciferol) twice daily for the whole duration of the study

Locations

Country	Name	City	State
Finland	Bone and Cartilage Research Unit, Clinical Research Centre, University of Kuopio	Kuopio

Sponsors (4)

Lead Sponsor	Collaborator
Kuopio University Hospital	Academy of Finland, Leiras-Nycomed, University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fractures		3 year follow-up	No
Secondary	falls		3 year follow-up	No
Secondary	bone mineral density measured by axial DXA, heel pDXA, heel QUS and distal forearm pQCT		3 year follow-up	No
Secondary	markers of bone metabolism		3 year follow-up	No
Secondary	serum vitamin-D levels		3 year follow-up	No
Secondary	serum calcium levels		3 year follow-up	No