Effect of treatment with an oral bisphosphonate on markers of bone formation and bone resorption in adults with alkpatonuria
| ISRCTN | ISRCTN12672997 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12672997 |
| Protocol serial number | 1 |
| Sponsor | University Medical Centre Utrecht (UMCU) (The Netherlands) |
| Funder | University Medical Centre Utrecht (UMCU) (The Netherlands) |
- Submission date
- 27/02/2007
- Registration date
- 27/02/2007
- Last edited
- 27/02/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr H W de Valk
Scientific
Scientific
University Medical Centre Utrecht (UMCU)
Department of Internal Medicine
P.O. Box 85500
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
| Phone | +31 (0)30 250 8323 |
|---|---|
| H.W.devalk@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Explorative trial |
| Secondary study design | Single-centre |
| Scientific title | |
| Study objectives | With this explorative trial we will investigate the effect of treatment with a bisphosphonate on markers of bone formation and bone resorption in patients with this rare metabolic disorder. Hypothesis: Treatment with a bisphosphonate leads to a decrease in the level of the marker of bone resorption in a period of three months. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Alkaptonuria |
| Intervention | Three months oral treatment with risendronate 5 mg per day |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Risendronate |
| Primary outcome measure(s) |
1. Change in bone markers |
| Key secondary outcome measure(s) |
Pain using the Visual Analogue Scale (VAS)-score |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 6 |
| Key inclusion criteria | 1. Patients with alkaptonuria 2. Osteopenia or osteoporose on Dual Energy X-ray Absorptiometry (DEXA)-scan 3. Age minimally 16 years |
| Key exclusion criteria | 1. Short life expectancy 2. Hepatic or renal disease 3. Excessive use of alcohol |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht (UMCU)
Utrecht
3584 CX
Netherlands
3584 CX
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
