FracturesPhase 4OSTPRE-FPSNCT00592917
OSTPRE-Fracture Prevention Study
A Phase 4 study testing calcium carbonate and cholecalciferol in people with Fractures and Osteoporosis, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Fractures, Osteoporosis
- What is being tested?
- calcium carbonate and cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,432 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2002to Oct 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Bone and Cartilage Research Unit, Clinical Research Centre, University of Kuopio
Kuopio, 70211
About this study
Official title: OSTPRE-FPS Prevention of Fractures and Falls in Postmenopausal Women With Calcium and Vitamin-D Supplementation - a Randomised Study
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.
Read the 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.
- Conditions
- Fractures, Osteoporosis
- Being tested
- calcium carbonate and cholecalciferol
- Keywords
- osteoporosis, fractures, risk of fracture, vitamin-D, calcium, falls, bone mineral density, bone metabolism
- Medical subject headings
- Fractures, Bone, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium carbonate and cholecalciferolDietary supplement
Also called Calcichew D3 forte (Leiras-Nycomed), ATC-code: A12AX
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
fractures
Measured: 3 year follow-up
Secondary outcomes (5)
falls
Measured: 3 year follow-up
bone mineral density measured by axial DXA, heel pDXA, heel QUS and distal forearm pQCT
Measured: 3 year follow-up
markers of bone metabolism
Measured: 3 year follow-up
serum vitamin-D levels
Measured: 3 year follow-up
serum calcium levels
Measured: 3 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startAug 2002
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland, Academy of Finland, Leiras-Nycomed
- Investigators
- Heikki P Kroger, Professor, Study chair, Department of Orthopedics, Traumatology and Hand Surgery, University Hospital of KuopioHeikki P Kroger, Professor, Study director, Department of Orthopedics, Traumatology and Hand Surgery, University Hospital of KuopioMarjo Tuppurainen, Professor, Principal investigator, Department of Gynecology and Obstetrics, University Hospital of Kuopio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592917
- Sponsor's protocol ID
- KUH5204512
- Other IDs
- 119/2001
- Acronym
- OSTPRE-FPS
- Status last verified
- Jan 2008
- First submitted
- 2 Jan 2008
- Last updated
- 14 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20204604Salovaara 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.
PubMed 20200964
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSTPRE-FPS Prevention of Fractures and Falls in Postmenopausal Women With Calcium and Vitamin-D Supplementation - a Randomised Study
- ClinicalTrials.gov ID
- NCT00592917
- Acronym / sponsor ID
- OSTPRE-FPS / KUH5204512
- Conditions
- Fractures, Osteoporosis
- Keywords
- osteoporosis, fractures, risk of fracture, vitamin-D, calcium, falls, bone mineral density, bone metabolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,432 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland, Academy of Finland, Leiras-Nycomed
- Study start
- Aug 2002
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ia | Active comparator | Dietary Supplement: calcium carbonate and cholecalciferol1718 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) |
| Ib | Active comparator | Dietary Supplement: calcium carbonate and cholecalciferolrandom 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 |
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcium carbonate and cholecalciferolAlso: Calcichew D3 forte (Leiras-Nycomed), ATC-code: A12AXone 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 | Dietary supplement | Ia, Ib |
Primary outcome
fractures
Time frame: 3 year follow-up
5 secondary outcomes
falls
Time frame: 3 year follow-up
bone mineral density measured by axial DXA, heel pDXA, heel QUS and distal forearm pQCT
Time frame: 3 year follow-up
markers of bone metabolism
Time frame: 3 year follow-up
serum vitamin-D levels
Time frame: 3 year follow-up
serum calcium levels
Time frame: 3 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2008.
- Derived from this study: PubMed 20204604Karkkainen 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.
- Derived from this study: PubMed 20200964Salovaara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heikki P Kroger, Professor study chair
Department of Orthopedics, Traumatology and Hand Surgery, University Hospital of Kuopio
Heikki P Kroger, Professor study director
Department of Orthopedics, Traumatology and Hand Surgery, University Hospital of Kuopio
Marjo Tuppurainen, Professor principal investigator
Department of Gynecology and Obstetrics, University Hospital of Kuopio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing calcium carbonate and cholecalciferol in people with Fractures and Osteoporosis, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fractures (time frame: 3 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00592917, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2008.