The effect of support by telephone on compliance with medication by osteoporosis patients using bisphosphonates objectivied by systematic control of serum bonemarkers

In recent medical literature it becomes clear that more than half of the
patients starting using a weekly oral bisfosfonates stops taking this
medication during the first year. The principal motives which are brought
forward is at one side the lack of conviction with the effectivity and on the
other hand the fear for side effects of the medication in short and longer
period. How compliance can be optimalised is not yet clear but previous studies
underline the importance of a combination of persuasiveness and willingness to
communicate.
In medical literature was shown that regular contact with the patients
encourages compliance.
Modest own investigation based on patients` self-reported compliance showed
that support given by telephone appears to increase compliance.

This study investigates to which degree osteoporosis patients taking weekly
oral bisfosfonate medication are influenced by by three telephone support calls
during the first year after starting this medication.
To verify the results of patients` self report on compliance samples of serum
bone markers will be used to objectify the results. Despite the lack of data on
postmenopausal standards s-CTX and s-PINP are reliable markers and especcially
investigated related to monitoring treatment of osteoporosis.

This study is divided in a randomised and a non-randomised part. Patients who
meet the inclusion criteria are invited to participate in the randomised part
of the study. Also two reference groups of patients wille be formed to observe
the developments of bone markers.

Randomised:
This is a randomised clinical trial. Goups 1 and 2 form the arm of oral
bisfosfonate users. Group 1 will have three telephone support calls and group 2
in this arm will not get these calls. Serum bone marker samples will be taken 5
times a year.

Non-randomised
Group 3 is a group of patients who receive because of medical reasons the
bisfosfonate once yearly intravenous instead of once weekly oral . This is a
group to observe the score and the development of bone markers influenced by a
once yearly intravenous administration to be related to the groups on once
weekly oral bisfosfonate medication. This group 3 will be contacted by
telephone once shortly after the first administration to observe the
experiences with the administration, possible side effects and the offered
nursing service.
Group 4 is a group of osteopenic patients and is a reference group as well.
This group is meant as a reference group for insight in the development of
serum bone markers in a normal not osteoporotic population; the results of this
group will be compared with the development of serum bonemarkers of patients
being treated with (oral) bisfosfonates

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.

There is a low risk: it concerns the implementation of the regular treatment of
patients with primary osteoporis .
The burden of investigation exists of taking bloodsamples of bonemarkers by
venepuncture five times during the year.
The patient are asked to complete questionnaires at start en finish of the
year.