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| autoid | 127 |
| crg_id | CRG030600056 |
| titleoftrial | Prevention of steroid-induced bone loss in chronic kidney diseases: A randomized, open-labeled, prospective study |
| acronymnoftrial | |
| website | http:// |
| identificationno | |
| leadprefix | Prof |
| leadsurname | Miura |
| leadgivennames | Soichiro |
| leadposition | Professor of Medicine |
| leaddepartment | Internal Medicine |
| leadorganisation | National Defense Medical College |
| leadaddress | 3-2 Namiki, Tokorozawa, Saitama 359-8513, Japan |
| leademail | miura@ndmc.ac.jp |
| leadphone | +81-4-2995-1609 |
| leadfax | +81-4-2996-5201 |
| leadsuffix | |
| contactprefix | |
| contactsurname | |
| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
| contactaddress | |
| contactemail | |
| contactphone | |
| contactfax | |
| funding | ngo |
| otherfunding | |
| fundingnameofsponsors | Bouei Igaku Shinkou Kai [ngo] |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | |
| actualstart | 03/2003 |
| proposedcompletiondate | 03/2006 |
| actualcompletiondate | |
| multi_center_study | no |
| numberofcentres | |
| multi_national_study | no |
| countrycentres | Japan |
| researchquestion | To examine whether bisphosphonate or vitamin D3 has beneficial effects on bone mineral density in patients with chronic kidney diseases being treated with high-dose corticosteroids, including pulse therapy |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | chronic kidney diseases |
| intervention1 | risedronate |
| intervention2 | alfacalcidol |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | 18-75 |
| totalrecruitment | 40 |
| inclusion | patients with glomerulonephritis and initiated high-dose corticosteroid therapy (more than 30 mg/day of prednisolone, including steroid pulse therapy) |
| exclusion | 1. Ccr <30ml/min
2. Young adult means of bone mineral density at the lumbar spine >130 or <80 3. Patients with previous treatment with steroids, bisphosphonates or vitamin D3 |
| primaryoutcomes | Change in bone mineral density at the lumbar spine |
| secondaryoutcomes | Bone fracture Adverse effects |
| reference |