OSTPRE-Fracture Prevention Study (OSTPRE-FPS)

This study has been completed.
Sponsor:
Collaborators:
University of Eastern Finland
Academy of Finland
Leiras-Nycomed
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00592917
First received: January 2, 2008
Last updated: January 11, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Fractures
Osteoporosis
Dietary Supplement: calcium carbonate and cholecalciferol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: OSTPRE-FPS Prevention of Fractures and Falls in Postmenopausal Women With Calcium and Vitamin-D Supplementation - a Randomised Study

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • fractures [ Time Frame: 3 year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • falls [ Time Frame: 3 year follow-up ] [ Designated as safety issue: No ]
  • bone mineral density measured by axial DXA, heel pDXA, heel QUS and distal forearm pQCT [ Time Frame: 3 year follow-up ] [ Designated as safety issue: No ]
  • markers of bone metabolism [ Time Frame: 3 year follow-up ] [ Designated as safety issue: No ]
  • serum vitamin-D levels [ Time Frame: 3 year follow-up ] [ Designated as safety issue: No ]
  • serum calcium levels [ Time Frame: 3 year follow-up ] [ Designated as safety issue: No ]

Enrollment: 3432
Study Start Date: August 2002
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ia
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
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
Other Name: Calcichew D3 forte (Leiras-Nycomed), ATC-code: A12AX
Active Comparator: Ib
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
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
Other Name: Calcichew D3 forte (Leiras-Nycomed), ATC-code: A12AX
No Intervention: IIa
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
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

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592917

Locations
Finland
Bone and Cartilage Research Unit, Clinical Research Centre, University of Kuopio
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
University of Eastern Finland
Academy of Finland
Leiras-Nycomed
Investigators
Study Chair: Heikki P Kroger, Professor Department of Orthopedics, Traumatology and Hand Surgery, University Hospital of Kuopio
Study Director: Heikki P Kroger, Professor Department of Orthopedics, Traumatology and Hand Surgery, University Hospital of Kuopio
Principal Investigator: Marjo Tuppurainen, Professor Department of Gynecology and Obstetrics, University Hospital of Kuopio
  More Information

No publications provided by Kuopio University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Heikki Kroger, Kuopio University Hospital, Dept of Orthopedics, Traumatology and Handsurgery
ClinicalTrials.gov Identifier: NCT00592917     History of Changes
Other Study ID Numbers: KUH5204512, 119/2001
Study First Received: January 2, 2008
Last Updated: January 11, 2008
Health Authority: Research Ethics Committee, Hospital District of Northern Savo, Finland:

Keywords provided by Kuopio University Hospital:
osteoporosis
fractures
risk of fracture
vitamin-D
calcium
falls
bone mineral density
bone metabolism

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium, Dietary
Cholecalciferol
Vitamin D
Ergocalciferols
Calcium Carbonate
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 20, 2014