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Effect of treatment with an oral bisphosphonate on markers of bone formation and bone resorption in adults with alkpatonuria.


- candidate number1367
- NTR NumberNTR431
- ISRCTNISRCTN12672997
- Date ISRCTN created27-feb-2007
- date ISRCTN requested18-nov-2005
- Date Registered NTR2-sep-2005
- Secondary IDs
- Public TitleEffect of treatment with an oral bisphosphonate on markers of bone formation and bone resorption in adults with alkpatonuria.
- Scientific TitleShort term effect of oral risedronate on markers of bone formation and resorption in patients with alkaptonuria.
- ACRONYMN/A
- hypothesisTreatment with a bisphosphonate leads to a decrease in the level of the marker of bone resoprtion in a periode of three months.
- Healt Condition(s) or Problem(s) studiedAlkaptonuria
- Inclusion criteria1. Patients with alkaptonuria;
2. Osteopenia or osteoporose on DEXA-scan;
3. Age minimally 16 years.
- Exclusion criteria1. Short life expectancy;
2. Hepatic or renal disease;
3. Excessive use of alcohol.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-sep-2005
- planned closingdate1-dec-2005
- Target number of participants6
- InterventionsThree months oral treatment with risendronate 5 mg per day.
- Primary outcome1. Change in bone markers;
2. Bone formation: Plasma alk. phosphatase;
3. Bone resorption: Urine Type I collagen cross-linked N-telopeptide.
- Secondary outcomePain using the VAS-score.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. H.W. Valk, de
- CONTACT for SCIENTIFIC QUERIESDrs. Z.M. Barriento Martinez
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryWith 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.
- Main changes (audit trail)
- RECORD3-sep-2005 - 1-okt-2008


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