Clinical trial NCT00592917: OSTPRE-Fracture Prevention Study
Official title: OSTPRE-FPS Prevention of Fractures and Falls in Postmenopausal Women With Calcium and Vitamin-D Supplementation - a Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fractures
Osteoporosis
Keywords: osteoporosis
fractures
risk of fracture
vitamin-D
calcium
falls
bone mineral density
bone metabolism
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
name: Academy of Finland
name: Leiras-Nycomed
First posted: 2008-01-14
Enrollment: 3432
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: fractures
timeFrame: 3 year follow-up
Secondary outcomes:
measure: falls
timeFrame: 3 year follow-up
measure: bone mineral density measured by axial DXA, heel pDXA, heel QUS and distal forearm pQCT
timeFrame: 3 year follow-up
measure: markers of bone metabolism
timeFrame: 3 year follow-up
measure: serum vitamin-D levels
timeFrame: 3 year follow-up
measure: serum calcium levels
timeFrame: 3 year follow-up
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Bone and Cartilage Research Unit, Clinical Research Centre, University of Kuopio
Study officials:
affiliation: Department of Orthopedics, Traumatology and Hand Surgery, University Hospital of Kuopio
name: Heikki P Kroger, Professor
role: STUDY_CHAIR
affiliation: Department of Orthopedics, Traumatology and Hand Surgery, University Hospital of Kuopio
name: Heikki P Kroger, Professor
role: STUDY_DIRECTOR
affiliation: Department of Gynecology and Obstetrics, University Hospital of Kuopio
name: Marjo Tuppurainen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karkkainen M, Tuppurainen M, Salovaara K, Sandini L, Rikkonen T, Sirola J, Honkanen R, Jurvelin J, Alhava E, Kroger H. Effect of calcium and vitamin D supplementation on bone mineral density in women aged 65-71 years: a 3-year randomized population-based trial (OSTPRE-FPS). Osteoporos Int. 2010 Dec;21(12):2047-55. doi: 10.1007/s00198-009-1167-8. Epub 2010 Mar 4.
citation: Salovaara K, Tuppurainen M, Karkkainen M, Rikkonen T, Sandini L, Sirola J, Honkanen R, Alhava E, Kroger H. Effect of vitamin D(3) and calcium on fracture risk in 65- to 71-year-old women: a population-based 3-year randomized, controlled trial--the OSTPRE-FPS. J Bone Miner Res. 2010 Jul;25(7):1487-95. doi: 10.1002/jbmr.48.