Hyperphosphatemia
Conditions
Brief summary
Patients enrolled in a previous study (SPD405-309), who were exposed to lanthanum carbonate (Fosrenol), were eligible to continue on any prescribed treatment for hyperphosphatemia, including lanthanum carbonate (Fosrenol), for an additional 5 years. Patients were being observed for any bone adverse events or other serious adverse events, as well as the collection of mortality data.
Interventions
DRUGLanthanum carbonate
Sponsors
Shire
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any patient who had exposure to lanthanum carbonate in SPD405-309
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Study-emergent Bone-related Adverse Events (AEs) | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of Study-emergent Deaths | 5 years |
Countries
Germany, United Kingdom, United States
Participant flow
Recruitment details
Followed subjects from study SPD405-309 (NCT00150540) for 5 years.
Participants by arm
| Arm | Count |
|---|---|
| 5-Year Observational Period Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths. | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative change | 2 |
| Overall Study | Death | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | 5-Year Observational Period |
|---|---|
| Age, Continuous | 54.1 Years STANDARD_DEVIATION 13.3 |
| Region of Enrollment Germany | 18 Participants |
| Region of Enrollment United Kingdom | 4 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 34 |
| serious Total, serious adverse events | 18 / 34 |
Outcome results
Primary
Number of Study-emergent Bone-related Adverse Events (AEs)
Time frame: 5 years
Population: Safety Set defined as all subjects who received at least one safety measurement during the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5-Year Observational Period | Number of Study-emergent Bone-related Adverse Events (AEs) | Fracture (8 subjects) | 9 Bone-related AEs |
| 5-Year Observational Period | Number of Study-emergent Bone-related Adverse Events (AEs) | Arthralgia (1 subject) | 2 Bone-related AEs |
| 5-Year Observational Period | Number of Study-emergent Bone-related Adverse Events (AEs) | Hyperparathyroidism tertiary | 1 Bone-related AEs |
| 5-Year Observational Period | Number of Study-emergent Bone-related Adverse Events (AEs) | Flat feet | 1 Bone-related AEs |
| 5-Year Observational Period | Number of Study-emergent Bone-related Adverse Events (AEs) | Fracture nonunion | 1 Bone-related AEs |
| 5-Year Observational Period | Number of Study-emergent Bone-related Adverse Events (AEs) | Intervertebral disc protrusion | 1 Bone-related AEs |
| 5-Year Observational Period | Number of Study-emergent Bone-related Adverse Events (AEs) | Osteoarthritis | 1 Bone-related AEs |
| 5-Year Observational Period | Number of Study-emergent Bone-related Adverse Events (AEs) | Osteonecrosis | 1 Bone-related AEs |
| 5-Year Observational Period | Number of Study-emergent Bone-related Adverse Events (AEs) | Osteopenia | 1 Bone-related AEs |
| 5-Year Observational Period | Number of Study-emergent Bone-related Adverse Events (AEs) | Osteoporosis | 1 Bone-related AEs |
| 5-Year Observational Period | Number of Study-emergent Bone-related Adverse Events (AEs) | Pain in extremity | 1 Bone-related AEs |
| 5-Year Observational Period | Number of Study-emergent Bone-related Adverse Events (AEs) | Renal osteodystrophy | 1 Bone-related AEs |
| 5-Year Observational Period | Number of Study-emergent Bone-related Adverse Events (AEs) | Tendonitis | 1 Bone-related AEs |
Secondary
Number of Study-emergent Deaths
Time frame: 5 years
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5-Year Observational Period | Number of Study-emergent Deaths | 3 Participants |