Trial Outcomes & Findings for Long-term Effect of Lanthanum Carbonate on Bone (NCT NCT00557323)
NCT ID: NCT00557323
Last Updated: 2021-07-13
Results Overview
Recruitment status
COMPLETED
Target enrollment
34 participants
Primary outcome timeframe
5 years
Results posted on
2021-07-13
Participant Flow
Followed subjects from study SPD405-309 (NCT00150540) for 5 years.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Administrative change
|
2
|
Baseline Characteristics
Long-term Effect of Lanthanum Carbonate on Bone
Baseline characteristics by cohort
| Measure |
5-Year Observational Period
n=34 Participants
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.
|
|---|---|
|
Age, Continuous
|
54.1 Years
STANDARD_DEVIATION 13.3 • n=39 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=39 Participants
|
|
Region of Enrollment
Germany
|
18 Participants
n=39 Participants
|
|
Region of Enrollment
United Kingdom
|
4 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Safety Set defined as all subjects who received at least one safety measurement during the study.
Outcome measures
| Measure |
5-Year Observational Period
n=34 Participants
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.
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|---|---|
|
Number of Study-emergent Bone-related Adverse Events (AEs)
Osteoporosis
|
1 Bone-related AEs
|
|
Number of Study-emergent Bone-related Adverse Events (AEs)
Fracture (8 subjects)
|
9 Bone-related AEs
|
|
Number of Study-emergent Bone-related Adverse Events (AEs)
Arthralgia (1 subject)
|
2 Bone-related AEs
|
|
Number of Study-emergent Bone-related Adverse Events (AEs)
Hyperparathyroidism tertiary
|
1 Bone-related AEs
|
|
Number of Study-emergent Bone-related Adverse Events (AEs)
Flat feet
|
1 Bone-related AEs
|
|
Number of Study-emergent Bone-related Adverse Events (AEs)
Fracture nonunion
|
1 Bone-related AEs
|
|
Number of Study-emergent Bone-related Adverse Events (AEs)
Intervertebral disc protrusion
|
1 Bone-related AEs
|
|
Number of Study-emergent Bone-related Adverse Events (AEs)
Osteoarthritis
|
1 Bone-related AEs
|
|
Number of Study-emergent Bone-related Adverse Events (AEs)
Osteonecrosis
|
1 Bone-related AEs
|
|
Number of Study-emergent Bone-related Adverse Events (AEs)
Osteopenia
|
1 Bone-related AEs
|
|
Number of Study-emergent Bone-related Adverse Events (AEs)
Pain in extremity
|
1 Bone-related AEs
|
|
Number of Study-emergent Bone-related Adverse Events (AEs)
Renal osteodystrophy
|
1 Bone-related AEs
|
|
Number of Study-emergent Bone-related Adverse Events (AEs)
Tendonitis
|
1 Bone-related AEs
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Safety Set
Outcome measures
| Measure |
5-Year Observational Period
n=34 Participants
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.
|
|---|---|
|
Number of Study-emergent Deaths
|
3 Participants
|
Adverse Events
5-Year Observational Period
Serious events: 18 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5-Year Observational Period
n=34 participants at risk
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.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Cardiac disorders
Angina pectoris
|
5.9%
2/34 • Number of events 2
Safety Set
|
|
Cardiac disorders
Aortic valve stenosis
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/34 • Number of events 2
Safety Set
|
|
Cardiac disorders
Cardiac arrest
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Cardiac disorders
Cardiac failure
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Cardiac disorders
Coronary artery disease
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Cardiac disorders
Ventricular fibrillation
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Endocrine disorders
Hyperparathyroidism tertiary
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
General disorders
Asthenia
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
General disorders
General physical health deterioration
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
General disorders
Malaise
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
General disorders
Multi-organ failure
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
General disorders
Pyrexia
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Infections and infestations
Bronchitis acute
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Infections and infestations
Diverticulitis
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Infections and infestations
Endocarditis
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Infections and infestations
Gangrene
|
2.9%
1/34 • Number of events 2
Safety Set
|
|
Infections and infestations
Gastroenteritis
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Infections and infestations
Sepsis
|
5.9%
2/34 • Number of events 2
Safety Set
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Infections and infestations
Urosepsis
|
5.9%
2/34 • Number of events 2
Safety Set
|
|
Injury, poisoning and procedural complications
Pacemaker complication
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
2.9%
1/34 • Number of events 3
Safety Set
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Investigations
Ejection fraction decreased
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Nervous system disorders
Cerebrovascular accident
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Renal and urinary disorders
Hematuria
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Renal and urinary disorders
Renal failure acute
|
2.9%
1/34 • Number of events 2
Safety Set
|
|
Renal and urinary disorders
Ureteric stenosis
|
5.9%
2/34 • Number of events 2
Safety Set
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.9%
1/34 • Number of events 2
Safety Set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.9%
1/34 • Number of events 3
Safety Set
|
|
Vascular disorders
Aneurysm arteriovenous
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Vascular disorders
Arterial occlusive disease
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Vascular disorders
Peripheral occlusive disease
|
2.9%
1/34 • Number of events 1
Safety Set
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
11.8%
4/34 • Number of events 4
Safety Set
|
Other adverse events
| Measure |
5-Year Observational Period
n=34 participants at risk
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.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Fracture
|
14.7%
5/34 • Number of events 5
Safety Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER