No registrations found.
ID
Source
Brief title
Health condition
Alkaptonuria.
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Change in bone markers;
2. Bone formation: Plasma alk. phosphatase;
3. Bone resorption: Urine Type I collagen cross-linked N-telopeptide.
Secondary outcome
Pain using the VAS-score.
Background summary
With this explorative trial we investigate the effect of treatment with a bisphosphonate on markers of bone formation and bone resorption in patients with this rare metabolic disorder.
Study objective
Treatment with a bisphosphonate leads to a decrease in the level of the marker of bone resoprtion in a periode of three months.
Study design
N/A
Intervention
Three months oral treatment with risendronate 5 mg per day.
Department of Internal Medicine,
P.O. Box 85500
H.W. Valk, de
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)30 2508323
H.W.devalk@umcutrecht.nl
Department of Internal Medicine,
P.O. Box 85500
H.W. Valk, de
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)30 2508323
H.W.devalk@umcutrecht.nl
Inclusion criteria
1. Patients with alkaptonuria;
2. Osteopenia or osteoporose on DEXA-scan;
3. Age minimally 16 years.
Exclusion criteria
1. Short life expectancy;
2. Hepatic or renal disease;
3. Excessive use of alcohol.
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 |
|---|---|
| NTR-new | NL391 |
| NTR-old | NTR431 |
| Other | : 1 |
| ISRCTN | ISRCTN12672997 |