Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/02/2007
Date assigned
27/02/2007
Last edited
27/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H W de Valk

ORCID ID

Contact details

University Medical Centre Utrecht (UMCU)
Department of Internal Medicine
P.O. Box 85500
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
+31 (0)30 250 8323
H.W.devalk@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Explorative trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Alkaptonuria

Intervention

Three months oral treatment with risendronate 5 mg per day

Intervention type

Drug

Phase

Not Specified

Drug names

Risendronate

Primary outcome measures

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 trial start date

01/09/2005

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with alkaptonuria
2. Osteopenia or osteoporose on Dual Energy X-ray Absorptiometry (DEXA)-scan
3. Age minimally 16 years

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

6

Participant exclusion criteria

1. Short life expectancy
2. Hepatic or renal disease
3. Excessive use of alcohol

Recruitment start date

01/09/2005

Recruitment end date

01/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht (UMCU)
Utrecht
3584 CX
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

Department of Internal Medicine
P.O. Box 85500
Utrecht
3584 CX
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Utrecht (UMCU) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes