osteoporosis
Conditions
Interventions
To group 1 and 2 a weekly oral bisfosfonate is prescribed.
Group 1 is offered support 3 times in the first year by a telephone call, group
2 will not get this support.
Sponsors
Reinier de Graaf Groep
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: There are two parts in the study: RCT and observational study. For the RCT (group 1 and 2) Female patients with osteoporosis to whom an oral bisfosfonate will be prescribed Age 50-85 years Legally capable After agreement they sign the informed consent form. ;For the observational study (reference group 3): Female patients with osteoporosis to whom an intravenous bisfosfonate will be prescribed for medical reasons Age 50-85 years Legally capable After agreement they sign the informed consent form. ;For the observational study (reference group 4): Female patients with osteopenia to whom no medication will be prescribed Age 50-85 years Legally capable After agreement they sign the informed consent form.
Exclusion criteria
Exclusion criteria: RCT: Male patients Age younger than 50 and older than 85 years Legally incapable;Observational: Age younger than 50 and older than 85 years Legally incapable No signed informed conscent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Compliance: Patients`self-reported compliance using a validated questionnaire. The percentage of patients (outcome proprotion) which is compliant is in our expectations and based om literature in group 1 (at least) 30% higher than in group 2. This will support our assumption that supportive telephone contacts do increase compliance. A Nivel questionnaire will be used to investigate patients` vision on medication and use of medication. 2. Serum bone-markers indicating bone-formation and bone-resorption bij laboratory examination (remaning percentage bone formation marker procollagen type 1 aminoterminal propeptide (s-P1NP) and remaining percentage bone-resorption marker C-terminal telopeptide (s-CTX). Compliance is defined as completely compliant medication taking during the year of investigation, using the objectivity of calculation of a decline of at least 40% in the concentrations serum bone-marker compared to the level of bone-markers measured before the start of taking medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reported side effects of the medication Calcium and vitamin D substitutes Attitudes towards taking medication | — |
Countries
Netherlands
Outcome results
None listed