OSTPRE-Fracture Prevention Study

NCT00592917 | Completed Phase 4

• 2 other identifiers: KUH5204512119/2001
• Study Type: interventional
• Target: 3,432
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures; Osteoporosis

Keywords

osteoporosis; fractures; risk of fracture; vitamin-D; calcium; falls; bone mineral density; bone metabolism

Outcome Measures

Primary Outcomes (1)

• fractures

  3 year follow-up

Secondary Outcomes (5)

• 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

Study Arms (4)

Ia

ACTIVE COMPARATOR

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

Ib

ACTIVE COMPARATOR

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

IIa

NO INTERVENTION

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)

IIb

NO INTERVENTION

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

Interventions

calcium carbonate and cholecalciferol DIETARY_SUPPLEMENT

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

Also known as: Calcichew D3 forte (Leiras-Nycomed), ATC-code: A12AX

Ia; Ib

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator
• Academy of Finland: collaborator
• Leiras-Nycomed: collaborator

Study Sites (1)

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

Kuopio, 70211, Finland

Location

Related Publications (2)

• 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.

  PMID: 20204604 DERIVED

• 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.

  PMID: 20200964 DERIVED

MeSH Terms

Conditions

Fractures, Bone; Osteoporosis

Interventions

Calcium Carbonate; Cholecalciferol

Condition Hierarchy (Ancestors)

Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Heikki P Kroger, Professor

  Department of Orthopedics, Traumatology and Hand Surgery, University Hospital of Kuopio

  STUDY CHAIR

• Heikki P Kroger, Professor

  Department of Orthopedics, Traumatology and Hand Surgery, University Hospital of Kuopio

  STUDY DIRECTOR

• Marjo Tuppurainen, Professor

  Department of Gynecology and Obstetrics, University Hospital of Kuopio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 14, 2008
• Study Start: August 1, 2002
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: January 14, 2008

Record last verified: 2008-01

Locations

FI (1)