OSTPRE-Fracture Prevention Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Fractures, Osteoporosis

Intervention / Treatment
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* Dietary Supplement: calcium carbonate and cholecalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ia<br>1718 subjects randomised for active calcium and vitamin-D -intervention, data collection with questionnaires at baseline and end of the study, data of falls and fractures in telephone-interviews annually except Ib (every four months) | Dietary Supplement: calcium carbonate and cholecalciferol<br>* 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<br>* Other names: Calcichew D3 forte (Leiras-Nycomed), ATC-code: A12AX;|
| Active Comparator: Ib<br>random sample of 292 of 1718 (Ia), data collection by questionnaires mentioned in Ia, data of falls an fractures by telephone interviews every four months, bone density measurements, clinical tests, laboratory sample collections at baseline and end of follow-up as described in study design | Dietary Supplement: calcium carbonate and cholecalciferol<br>* 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<br>* Other names: Calcichew D3 forte (Leiras-Nycomed), ATC-code: A12AX;|
| No Intervention: IIa<br>1714 subjects randomised to no intervention group, data collection with questionnaires at baseline and end of the study, data of falls and fractures in telephone-interviews annually except IIb (every four months) | |
| No Intervention: IIb<br>random sample of 314 of 1714 (IIa), data collection by questionnaires mentioned in IIa, data of falls an fractures by telephone interviews every four months, bone density measurements, clinical tests, laboratory sample collections at baseline and end of follow-up as described in study design | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fractures |  | 3 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| falls |  | 3 year follow-up | 
| bone mineral density measured by axial DXA, heel pDXA, heel QUS and distal forearm pQCT |  | 3 year follow-up | 
| markers of bone metabolism |  | 3 year follow-up | 
| serum vitamin-D levels |  | 3 year follow-up | 
| serum calcium levels |  | 3 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, fractures, risk of fracture, vitamin-D, calcium, falls, bone mineral density, bone metabolism