OSTPRE-Fracture Prevention Study (OSTPRE-FPS)

Kuopio University Hospital

Status and phase: Completed; Phase 4

Conditions: Osteoporosis; Fractures

Treatments: Dietary Supplement: calcium carbonate and cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT00592917

KUH5204512

119/2001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,432 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

3,432 participants in 4 patient groups

Ia

Active Comparator group

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)

Treatment:

Dietary Supplement: calcium carbonate and cholecalciferol

Ib

Active Comparator group

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

Treatment:

Dietary Supplement: calcium carbonate and cholecalciferol

IIa

No Intervention group

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)

IIb

No Intervention group

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