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 |
| Secondary identifying numbers | 1 |
- 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
| Study design | Explorative trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Risendronate |
| Primary outcome measure | 1. Change in bone markers 2. Bone formation: plasma alkaline phosphatase 3. Bone resorption: urine type I collagen cross-linked N-telopeptide |
| Secondary outcome measures | Pain using the Visual Analogue Scale (VAS)-score |
| Overall study start date | 01/09/2005 |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 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
Sponsor information
University Medical Centre Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Internal Medicine
P.O. Box 85500
Utrecht
3584 CX
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Hospital/treatment centre
University Medical Centre Utrecht (UMCU) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
