Trial · NCT00523341
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 48
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | 84 months | A serious adverse event (SAE) is defined as an adverse event that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is other significant medical hazard. Treatment-related adverse events includes only events for which the investigator indicated there was a reasonable possibility they may have been caused by study drug. The following were classified as adverse events of interest (events that are considered to be identified or potential risks of denosumab treatment): positively adjudicated osteonecrosis of the jaw, positively adjudicated atypical femoral fracture, hypocalcemia, adverse events potentially related to hypersensitivity, serious infection (including bacterial cellulitis), malignancy, cardiac disorders, vascular disorders, fracture healing complications, eczema, acute pancreatitis, and musculoskeletal pain. |
| Primary | Number of Participants With Laboratory Toxicities of Grade ≥ 3 | 84 months | Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity. |
| Primary | Number of Participants With Antibodies to Denosumab | Every 12 months through Month 84 | |
| Secondary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. |
| Secondary | Percent Change From Baseline in Total Hip Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. |
| Secondary | Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. |
| Secondary | Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | 1/3 radius bone mineral density was measured in a subset of participants by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. |
| Secondary | Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84 | Lumbar spine bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants. |
| Secondary | Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84 | Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants. |
| Secondary | Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84 | Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants. |
| Secondary | Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60, and 84 | 1/3 radius BMD was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants. |
| Secondary | Number of Participants With New Vertebral Fractures | 84 months | A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4, excluding any fracture associated with high trauma severity or a pathologic fracture. |
| Secondary | Number of Participants With Non-Vertebral Fractures | 84 months | Non-vertebral fractures (osteoporotic) were defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI) confirming the fracture, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded. |
| Secondary | Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit | Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84 | Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study. |
| Secondary | Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit | Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84 | Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new sparticipants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study. |
| Secondary | Percent Change From Study 20030216 Baseline in CTX-1 by Visit | Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84 | Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study. |
| Secondary | Percent Change From Study 20030216 Baseline in P1NP by Visit | Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84 | Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study. |
| Secondary | Percent Change From Baseline in Albumin-adjusted Serum Calcium at Day 10 | Baseline (of extension study) and day 10 | |
| Secondary | Serum Denosumab Concentration | Baseline (pre-dose in extension study), day 10, and Months 3, 4 and 6 (pre-dose) | Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 0.8 ng/mL. Values of 0 in the table below indicate data below the lower limit of quantification. |
| Secondary | Bone Histomorphometry: Cancellous Bone Volume | Month 24 and month 84 | Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cancellous (trabecular) bone volume is the percent of the total marrow cavity that is occupied by cancellous bone (both mineralized and non-mineralized) measured by quantitative histomorphometry. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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