search
Back to results

OSTPRE-Fracture Prevention Study (OSTPRE-FPS)

Primary Purpose

Fractures, Osteoporosis

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
calcium carbonate and cholecalciferol
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fractures focused on measuring osteoporosis, fractures, risk of fracture, vitamin-D, calcium, falls, bone mineral density, bone metabolism

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Bone and Cartilage Research Unit, Clinical Research Centre, University of Kuopio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

No Intervention

No Intervention

Arm Label

Ia

Ib

IIa

IIb

Arm Description

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)

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

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)

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

Outcomes

Primary Outcome Measures

fractures

Secondary Outcome Measures

falls
bone mineral density measured by axial DXA, heel pDXA, heel QUS and distal forearm pQCT
markers of bone metabolism
serum vitamin-D levels
serum calcium levels

Full Information

First Posted
January 2, 2008
Last Updated
January 11, 2008
Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland, Academy of Finland, Leiras-Nycomed
search

1. Study Identification

Unique Protocol Identification Number
NCT00592917
Brief Title
OSTPRE-Fracture Prevention Study
Acronym
OSTPRE-FPS
Official Title
OSTPRE-FPS Prevention of Fractures and Falls in Postmenopausal Women With Calcium and Vitamin-D Supplementation - a Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland, Academy of Finland, Leiras-Nycomed

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Osteoporosis
Keywords
osteoporosis, fractures, risk of fracture, vitamin-D, calcium, falls, bone mineral density, bone metabolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3432 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ia
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Ib
Arm Type
Active Comparator
Arm Description
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
Arm Title
IIa
Arm Type
No Intervention
Arm Description
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)
Arm Title
IIb
Arm Type
No Intervention
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
calcium carbonate and cholecalciferol
Other Intervention Name(s)
Calcichew D3 forte (Leiras-Nycomed), ATC-code: A12AX
Intervention Description
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
Primary Outcome Measure Information:
Title
fractures
Time Frame
3 year follow-up
Secondary Outcome Measure Information:
Title
falls
Time Frame
3 year follow-up
Title
bone mineral density measured by axial DXA, heel pDXA, heel QUS and distal forearm pQCT
Time Frame
3 year follow-up
Title
markers of bone metabolism
Time Frame
3 year follow-up
Title
serum vitamin-D levels
Time Frame
3 year follow-up
Title
serum calcium levels
Time Frame
3 year follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heikki P Kroger, Professor
Organizational Affiliation
Department of Orthopedics, Traumatology and Hand Surgery, University Hospital of Kuopio
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Heikki P Kroger, Professor
Organizational Affiliation
Department of Orthopedics, Traumatology and Hand Surgery, University Hospital of Kuopio
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marjo Tuppurainen, Professor
Organizational Affiliation
Department of Gynecology and Obstetrics, University Hospital of Kuopio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bone and Cartilage Research Unit, Clinical Research Centre, University of Kuopio
City
Kuopio
ZIP/Postal Code
70211
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20204604
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.
Results Reference
derived
PubMed Identifier
20200964
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.
Results Reference
derived

Learn more about this trial

OSTPRE-Fracture Prevention Study

We'll reach out to this number within 24 hrs