Primary Objective: To evaluate the change in serum βCTX in patients who start with HCQ treatment.Secondary Objective(s): To evaluate the change in serum PINP and BAP in patients who start with HCQ treatment
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome of this study is to evaluate the changes in beta-CTX due to
HCQ treatment.
Secondary outcome
To evaluate the change in serum PINP and BAP in patients who start with HCQ
treatment
Background summary
In our previous study we found that patients with pSS have higner bone mass
compared to healthy controls.
We performed a biochemical pilot study to evaluate the effects of HCQ on bone
metabolism. The preliminary data of this study revealed that HCQ has few effect
on bone formation, however, bone resorption was significantly decreased
compared to the controls. This effect was monitored after three weeks. The data
supports our clinical data from the previous study. However, the duration and
dose of HCQ in those patients are not known.
Study objective
Primary Objective:
To evaluate the change in serum βCTX in patients who start with HCQ treatment.
Secondary Objective(s):
To evaluate the change in serum PINP and BAP in patients who start with HCQ
treatment
Study design
The current study is designed as an observational study
Patients will be recruited at the outpatient clinic of the Internal Medicine in
the Erasmus Medical Centre or at the Department of Rheumatology of both the
Maasstad Hospital and Sint Franciscus Gasthuis.
All patients with inflammatory arthritis, pSS, sarcoidosis, RA or SLE and
therefore require treatment with HCQ will be invited to participate in the
present study. We will not administer HCQ to healthy controls or patients who
do not need HCQ for its current condition. In the current study we measure
serum BTMs at baseline and three months after treatment. The following BTMs
will be measured: PINP, BAP and ßCTX. Also, we will measure all participants
vitamin D status.
In addition, we will collect demographical data from all participants such as
BMI and smoking history.
We will store blood samples of every participant.
Study burden and risks
In the current study, patients only have to give extra blood. In total, two
times 80mL extra blood will be collected. There is no risk involved during the
study for patient*s health.
's-Gravendijkwal 230
Rotterdam 3015CE
NL
's-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
Age > 18 years
Patients with pSS, sarcoidosis, RA or SLE who start with HCQ
Exclusion criteria
Other underlying auto-immune disease
Use of medications against osteoporosis (e.g. bisphosphonates)
Severe vitamin D deficiency (serum level < 20 nmol/L)
Untreated hyperthyroidism
Untreated hyperparathyroidism
Use of corticosteroids (prednisone equivalent of > 7.5 mg for > 3 months in the last year)
Multiple myeloma
Mastocytosis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51938.078.14 |