Clinical Trial Details
| Trial ID: | L1620 |
| Source ID: | NCT00261950 |
| Associated Drug: | Sensipar (Cinacalcet Hcl) |
| Title: | Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease |
| Acronym: | BONAFIDE |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00261950/results |
| Conditions: | Secondary Hyperparathyroidism |
| Interventions: | DRUG: Sensipar (Cinacalcet HCl) |
| Outcome Measures: | Primary: Change From Baseline to End of Study in Bone Formation Rate (BFR), Baseline to week 52 | Secondary: Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP), Baseline to weeks 40-52|Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP), Baseline to weeks 40-52|Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP), Baseline to weeks 40-52|Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52, Baseline to week 52|Percent Change From Baseline in N - Telopeptide (NTx) at Week 52, Baseline to week 52|Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP), Baseline to weeks 40-52|Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter), Osteoblast Perimeter was calculated as "Osteoblast Perimeter/Osteoid Perimeter \* 100", Baseline to week 52|Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter), Osteoclast Perimeter was calculated as "Osteoclast Perimeter/Eroded Perimeter \* 100", Baseline to week 52|Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area, Categorisation at each timepoint was based on fibrosis area as a percentage of tissue area (Fibrosis Area/Tissue Area \* 100), Baseline to week 52|Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter, Eroded Perimeter/Bone Perimeter was calculated as "Eroded Perimeter/Bone Perimeter \* 100", Baseline to week 52|Percent Change From Baseline in Osteocalcin (OC) at Week 52, Baseline to week 52|Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52, Baseline to week 52 |
| Sponsor/Collaborators: | Sponsor: Amgen |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 110 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2006-05 |
| Completion Date: | 2011-05 |
| Results First Posted: | 2013-12-04 |
| Last Update Posted: | 2014-07-21 |
| Locations: | Research Site, Phoenix, Arizona, 85012, United States|Research Site, Los Angeles, California, 90095, United States|Research Site, Denver, Colorado, 80220, United States|Research Site, New Haven, Connecticut, 06511, United States|Research Site, Fort Lauderdale, Florida, 33334, United States|Research Site, Evanston, Illinois, 60201, United States|Research Site, New Orleans, Louisiana, 70121, United States|Research Site, Baltimore, Maryland, 21205, United States|Research Site, St Louis, Missouri, 63110, United States|Research Site, Teaneck, New Jersey, 07666, United States|Research Site, Bronx, New York, 10467, United States|Research Site, Flushing, New York, 11355, United States|Research Site, Great Neck, New York, 11021, United States|Research Site, New York, New York, 10032, United States|Research Site, Allentown, Pennsylvania, 18103, United States|Research Site, Houston, Texas, 77076, United States|Research Site, Antwerpen, 2020, Belgium|Research Site, Antwerpen, 2060, Belgium|Research Site, Bruxelles, 1070, Belgium|Research Site, Leuven, 3000, Belgium|Research Site, Liege, 4000, Belgium|Research Site, Hradec Kralove, 500 05, Czech Republic|Research Site, Praha 6, 169 00, Czech Republic|Research Site, Budapest, 1083, Hungary|Research Site, Debrecen, 4012, Hungary|Research Site, Gyor, 9023, Hungary|Research Site, Miskolc, 3526, Hungary|Research Site, Nyiregyhaza, 4400, Hungary|Research Site, Avellino, 83100, Italy|Research Site, Cremona, 26100, Italy|Research Site, Genova, 16132, Italy|Research Site, Milano, 20162, Italy|Research Site, Ortona CH, 66026, Italy|Research Site, Ostia RM, 00122, Italy|Research Site, Roma (RM), 00133, Italy|Research Site, Roma, 00149, Italy|Research Site, Roma, 00184, Italy|Research Site, Skopje, 1000, Macedonia, The Former Yugoslav Republic of|Research Site, Krakow, 31-501, Poland|Research Site, Lodz, 90-153, Poland|Research Site, Wroclaw, 50-556, Poland|Research Site, Porto, PR, 4250-499, Portugal|Research Site, Almada, 2800-455, Portugal|Research Site, Estoril, 2765-294, Portugal|Research Site, Guimarães, 4810-273, Portugal|Research Site, Porto, 4200-072, Portugal|Research Site, Vila Franca de Xira, 2600-076, Portugal|Research Site, Santander, Cantabria, 39008, Spain|Research Site, Barcelona, Cataluña, 08003, Spain|Research Site, Barcelona, Cataluña, 08036, Spain|Research Site, Alcorcón, Madrid, 28922, Spain|Research Site, Madrid, 28046, Spain|Research Site, Zurich, 8091, Switzerland|Research Site, Izmir, 35360, Turkey|Research Site, Manchester, M13 9WL, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00261950 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|