Trial Outcomes & Findings for Renal Osteodystrophy: An Individual Management Approach (NCT NCT02440581)
NCT ID: NCT02440581
Last Updated: 2023-01-05
Results Overview
At one year the investigators will asses bone mass using QCT of the total hip and compare one year changes in bone mass between the treatment and control groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
141 participants
Primary outcome timeframe
One Year (at baseline and one year)
Results posted on
2023-01-05
Participant Flow
Participant milestones
| Measure |
Control, Low Turnover
No intervention in low turnover osteoporosis control group.
|
Treatment, Low Turnover
Low turnover osteoporosis group treated with teriparatide and cinacalcet.
Teriparatide
Cinacalcet
|
Control, High Turnover
No intervention in high turnover osteoporosis control group.
|
Treatment, High Turnover
High turnover osteoporosis group treated with alendronate.
Alendronate
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
37
|
24
|
50
|
30
|
|
Overall Study
COMPLETED
|
32
|
13
|
37
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
13
|
14
|
Reasons for withdrawal
| Measure |
Control, Low Turnover
No intervention in low turnover osteoporosis control group.
|
Treatment, Low Turnover
Low turnover osteoporosis group treated with teriparatide and cinacalcet.
Teriparatide
Cinacalcet
|
Control, High Turnover
No intervention in high turnover osteoporosis control group.
|
Treatment, High Turnover
High turnover osteoporosis group treated with alendronate.
Alendronate
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
7
|
5
|
|
Overall Study
Transplanted
|
1
|
0
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
11
|
3
|
7
|
Baseline Characteristics
Renal Osteodystrophy: An Individual Management Approach
Baseline characteristics by cohort
| Measure |
Control, Low Turnover
n=37 Participants
No intervention in low turnover osteoporosis control group.
|
Treatment, Low Turnover
n=24 Participants
Low turnover osteoporosis group treated with teriparatide and cinacalcet.
Teriparatide
Cinacalcet
|
Control, High Turnover
n=50 Participants
No intervention in high turnover osteoporosis control group.
|
Treatment, High Turnover
n=30 Participants
High turnover osteoporosis group treated with alendronate.
Alendronate
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
89 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
52 Participants
n=36 Participants
|
|
Age, Continuous
|
62.68 years
STANDARD_DEVIATION 1.95 • n=93 Participants
|
62.67 years
STANDARD_DEVIATION 2.83 • n=4 Participants
|
59.14 years
STANDARD_DEVIATION 1.73 • n=27 Participants
|
59.83 years
STANDARD_DEVIATION 2.28 • n=483 Participants
|
61.035 years
STANDARD_DEVIATION 1.49 • n=36 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
60 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
81 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 participants
n=93 Participants
|
9 participants
n=4 Participants
|
24 participants
n=27 Participants
|
6 participants
n=483 Participants
|
49 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
27 participants
n=93 Participants
|
15 participants
n=4 Participants
|
26 participants
n=27 Participants
|
24 participants
n=483 Participants
|
92 participants
n=36 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=93 Participants
|
24 participants
n=4 Participants
|
50 participants
n=27 Participants
|
30 participants
n=483 Participants
|
141 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: One Year (at baseline and one year)At one year the investigators will asses bone mass using QCT of the total hip and compare one year changes in bone mass between the treatment and control groups.
Outcome measures
| Measure |
Control, Low Turnover
n=37 Participants
No intervention in low turnover osteoporosis control group.
|
Treatment, Low Turnover
n=24 Participants
Low turnover osteoporosis group treated with teriparatide and cinacalcet.
Teriparatide
Cinacalcet
|
Control, High Turnover
n=50 Participants
No intervention in high turnover osteoporosis control group.
|
Treatment, High Turnover
n=30 Participants
High turnover osteoporosis group treated with alendronate.
Alendronate
|
|---|---|---|---|---|
|
Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip
|
-10.71 g/cm^3
Standard Error 4.73
|
5.72 g/cm^3
Standard Error 4.74
|
-3.52 g/cm^3
Standard Error 3.36
|
.2 g/cm^3
Standard Error 5.67
|
SECONDARY outcome
Timeframe: One year (at baseline and one year)At one year the investigators will asses differences between the treatment and control groups in changes in Coronary Artery Calcifications by MDCT. 1 Yr. Change in Sqrt CAC Vol.
Outcome measures
| Measure |
Control, Low Turnover
n=37 Participants
No intervention in low turnover osteoporosis control group.
|
Treatment, Low Turnover
n=24 Participants
Low turnover osteoporosis group treated with teriparatide and cinacalcet.
Teriparatide
Cinacalcet
|
Control, High Turnover
n=50 Participants
No intervention in high turnover osteoporosis control group.
|
Treatment, High Turnover
n=30 Participants
High turnover osteoporosis group treated with alendronate.
Alendronate
|
|---|---|---|---|---|
|
Change in Coronary Artery Calcifications by Multiple Detector Computed Tomography (MDCT)
|
2.78 Hounsfield Unit
Standard Error 1.51
|
4.48 Hounsfield Unit
Standard Error 1.83
|
4.97 Hounsfield Unit
Standard Error 1.89
|
3.47 Hounsfield Unit
Standard Error 1.28
|
SECONDARY outcome
Timeframe: 1 Year (at baseline and one year)Population: 1 Yr. Change in PTH
Bone markers of bone activity tracked over time for changes.1 Yr. Change in PTH
Outcome measures
| Measure |
Control, Low Turnover
n=37 Participants
No intervention in low turnover osteoporosis control group.
|
Treatment, Low Turnover
n=24 Participants
Low turnover osteoporosis group treated with teriparatide and cinacalcet.
Teriparatide
Cinacalcet
|
Control, High Turnover
n=50 Participants
No intervention in high turnover osteoporosis control group.
|
Treatment, High Turnover
n=30 Participants
High turnover osteoporosis group treated with alendronate.
Alendronate
|
|---|---|---|---|---|
|
Change in Serum Biochemical Bone Markers of Bone Activity - Parathyroid Hormone (PTH)
|
89 pg/ml
Standard Error 32.3
|
379 pg/ml
Standard Error 118.6
|
-125 pg/ml
Standard Error 81.2
|
-240 pg/ml
Standard Error 126.5
|
SECONDARY outcome
Timeframe: 1 year (at baseline and one year)Population: 1 Yr. Change in BSAP
Bone markers of bone activity tracked over time for changes.1 Yr. Change in BSAP
Outcome measures
| Measure |
Control, Low Turnover
n=37 Participants
No intervention in low turnover osteoporosis control group.
|
Treatment, Low Turnover
n=24 Participants
Low turnover osteoporosis group treated with teriparatide and cinacalcet.
Teriparatide
Cinacalcet
|
Control, High Turnover
n=50 Participants
No intervention in high turnover osteoporosis control group.
|
Treatment, High Turnover
n=30 Participants
High turnover osteoporosis group treated with alendronate.
Alendronate
|
|---|---|---|---|---|
|
Change in Serum Biochemical Bone Markers of Bone Activity - Bone-specific Alkaline Phosphatase (BSAP)
|
.61 pg/ml
Standard Error 3.683
|
-1.01 pg/ml
Standard Error 4.616
|
-8.92 pg/ml
Standard Error 6.121
|
-10.36 pg/ml
Standard Error 5.522
|
SECONDARY outcome
Timeframe: 1 Year (at baseline and 1 year)Bone markers of bone activity tracked over time for changes. 1 Yr. Change in FGF-23
Outcome measures
| Measure |
Control, Low Turnover
n=37 Participants
No intervention in low turnover osteoporosis control group.
|
Treatment, Low Turnover
n=24 Participants
Low turnover osteoporosis group treated with teriparatide and cinacalcet.
Teriparatide
Cinacalcet
|
Control, High Turnover
n=50 Participants
No intervention in high turnover osteoporosis control group.
|
Treatment, High Turnover
n=30 Participants
High turnover osteoporosis group treated with alendronate.
Alendronate
|
|---|---|---|---|---|
|
Change in Serum Biochemical Bone Markers of Bone Activity - Fibroblast Growth Factor 23 (FGF23)
|
985 pg/ml
Standard Error 1611
|
326 pg/ml
Standard Error 1114
|
3337 pg/ml
Standard Error 1427
|
607 pg/ml
Standard Error 467
|
Adverse Events
Control, Low Turnover
Serious events: 16 serious events
Other events: 16 other events
Deaths: 0 deaths
Treatment, Low Turnover
Serious events: 10 serious events
Other events: 16 other events
Deaths: 0 deaths
Control, High Turnover
Serious events: 21 serious events
Other events: 19 other events
Deaths: 7 deaths
Treatment, High Turnover
Serious events: 16 serious events
Other events: 17 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Control, Low Turnover
n=37 participants at risk
No intervention in low turnover osteoporosis control group.
|
Treatment, Low Turnover
n=24 participants at risk
Low turnover osteoporosis group treated with teriparatide and cinacalcet.
Teriparatide
Cinacalcet
|
Control, High Turnover
n=50 participants at risk
No intervention in high turnover osteoporosis control group.
|
Treatment, High Turnover
n=30 participants at risk
High turnover osteoporosis group treated with alendronate.
Alendronate
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Acute blood loss anemia
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Blood and lymphatic system disorders
Eliquis-associated bleeding
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Blood and lymphatic system disorders
Scrotal hematoma
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Cardiac disorders
A. fib
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Cardiac disorders
Heart attack
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Cardiac disorders
Hypotension
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Eye disorders
Orbital cellulitis
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Eye disorders
Retinal detachment
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Gastrointestinal disorders
Blood in stool
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Gastrointestinal disorders
Diverticulitis, hypoglycemia
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
GI bleed
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
General disorders
Death
|
13.5%
5/37 • Years 1-5
|
29.2%
7/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
General disorders
Fatigues/weakness
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
General disorders
Generalized weakness/fall
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
General disorders
Weakness
|
0.00%
0/37 • Years 1-5
|
16.7%
4/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Infections and infestations
Bacteremia
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Infections and infestations
Cellulitis
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Infections and infestations
COVID-19
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Infections and infestations
Flu
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Infections and infestations
Flu A
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Infections and infestations
Flu/bronchitis
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Infections and infestations
Foot Infection
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Infections and infestations
Left foot infection
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Infections and infestations
Mono/RSV
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Infections and infestations
MRSA bacteremia
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Infections and infestations
Peritonitis
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Infections and infestations
Sepsis
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Infections and infestations
Sepsis s/p UTI
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Injury, poisoning and procedural complications
Fall
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Femur fracture
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left foot fracture
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left hand fracture
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left hip fracture
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left hip pain
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left hip replacement s/p fracture
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left knee pain
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Lumbar/cervical stenosis
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Pinched Nerve
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Right hip pain
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Right leg fracture
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Possible thyroid cancer
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Nervous system disorders
Altered mental status
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Nervous system disorders
Altered mental status and weakness
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Nervous system disorders
Decreased LOC
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Nervous system disorders
Slurred speech
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Renal and urinary disorders
Blocked PD catheter
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Renal and urinary disorders
Fluid overload
|
2.7%
1/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
4.0%
2/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Renal and urinary disorders
Hematuria
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Renal and urinary disorders
Polycystic kidney disease
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Renal and urinary disorders
UTI
|
0.00%
0/37 • Years 1-5
|
8.3%
2/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty breathing
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
8.1%
3/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia with SOA
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia/bronchitis
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory/cardiac arrest
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
SOA
|
0.00%
0/37 • Years 1-5
|
8.3%
2/24 • Years 1-5
|
4.0%
2/50 • Years 1-5
|
6.7%
2/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
SOA, chest tightness
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
SOA/fluid overload, hyperglycemia, pneumonia
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
URI with ascites
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Skin and subcutaneous tissue disorders
Right foot ulcer
|
0.00%
0/37 • Years 1-5
|
8.3%
2/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Surgical and medical procedures
Right nephrectomy
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Surgical and medical procedures
Scheduled sinus surgery
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Vascular disorders
AV graft infection
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Vascular disorders
CVA
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Vascular disorders
Fistula repair
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Vascular disorders
Left great toe amputation
|
0.00%
0/37 • Years 1-5
|
8.3%
2/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Vascular disorders
Left metatarsal amputations
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Vascular disorders
Left third toe gangrene
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Vascular disorders
Occluded fistula
|
0.00%
0/37 • Years 1-5
|
8.3%
2/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Vascular disorders
Right transmetatarsal amputation
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
Other adverse events
| Measure |
Control, Low Turnover
n=37 participants at risk
No intervention in low turnover osteoporosis control group.
|
Treatment, Low Turnover
n=24 participants at risk
Low turnover osteoporosis group treated with teriparatide and cinacalcet.
Teriparatide
Cinacalcet
|
Control, High Turnover
n=50 participants at risk
No intervention in high turnover osteoporosis control group.
|
Treatment, High Turnover
n=30 participants at risk
High turnover osteoporosis group treated with alendronate.
Alendronate
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Left leg contusion
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Blood and lymphatic system disorders
Possible blood clot in leg
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Cardiac disorders
Chest pain
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Cardiac disorders
Elevated BP during dialysis
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Cardiac disorders
Hypotension
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
10.0%
3/30 • Years 1-5
|
|
Cardiac disorders
Palpitations
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Cardiac disorders
SVT
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Ear and labyrinth disorders
Ruptured right tympanic membrane
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Endocrine disorders
Increased PTH
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Eye disorders
Left red eye
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Eye disorders
Red, painful right gr toe
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Eye disorders
Visual impairment
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Abdominal cramps, nausea/vomiting
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Abdominal pain, nausea/vomiting
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Abdominal swelling
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Constipation
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Diarrhea
|
5.4%
2/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
6.7%
2/30 • Years 1-5
|
|
Gastrointestinal disorders
N/V, diarrhea
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Nausea
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Nausea/coughing
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Gastrointestinal disorders
Nausea/diarrhea
|
2.7%
1/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.00%
0/37 • Years 1-5
|
8.3%
2/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Nausea/vomiting, lightheadedness
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Nausea/vomiting/
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Reflux/vomiting
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Stomach pain
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Gastrointestinal disorders
Stomach virus
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
General disorders
Fatigue
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
General disorders
Fatigue, muscle ache
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
General disorders
Front tooth removal
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
General disorders
Headache
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
General disorders
Malaise
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
General disorders
Poor appetite
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
General disorders
Right side pain
|
5.4%
2/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
General disorders
Weakness
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Infections and infestations
Cellulitis
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Infections and infestations
Fever
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Infections and infestations
Influenza
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Infections and infestations
Laryngitis
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Infections and infestations
Left arm infection
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Infections and infestations
Left lower extremity wound
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Infections and infestations
Peritonitis
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Infections and infestations
Sinus infection
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Infections and infestations
Viral syndrome
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Injury, poisoning and procedural complications
Fall
|
10.8%
4/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Injury, poisoning and procedural complications
Frequent falls
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Injury, poisoning and procedural complications
Right toenail avulsion
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Metabolism and nutrition disorders
Dizziness
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Metabolism and nutrition disorders
Weight loss
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Bilateral heel pain
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Bilateral leg aches
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Bilateral leg cramps
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Bilateral leg pain
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
4.0%
2/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Bilateral leg weakness
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Bilateral shoulder pain
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
4.0%
2/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Bilateral thigh pain
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
BL wrist pain and right thumb pain
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Bruised ribs
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Immobility
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left arm pain
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left foot pain
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left foot/ankle pain
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left forearm pain
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left hip injury
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left hip pain
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
4.0%
2/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left hip pain/weakness
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left knee pain
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left rib fracture
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left rib/abdominal pain
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left shoulder pain
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Left side pain
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Leg aches
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Leg weakness
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Low back/hip pain
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Right ankle fracture
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Right arm swelling
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Right carpal tunnel
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Right foot pain
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Right hip pain
|
5.4%
2/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Right knee pain
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Right rib pain
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Right wrist synovitis
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Second ankle fracture
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Musculoskeletal and connective tissue disorders
Swelling at lower extremity prosthesis
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Nervous system disorders
Appetite suppression
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Nervous system disorders
BL neuropathy
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Nervous system disorders
Forgetfulness
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Product Issues
Forteo pen ran out early
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Product Issues
Teriparatide injection issues
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Renal and urinary disorders
Possible UTI
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Renal and urinary disorders
UTI
|
0.00%
0/37 • Years 1-5
|
8.3%
2/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Asthma symptoms
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Breathing difficulty
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Cough/congestion
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty breathing
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
6.7%
2/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
5.4%
2/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
SOA
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
6.7%
2/30 • Years 1-5
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
4.0%
2/50 • Years 1-5
|
6.7%
2/30 • Years 1-5
|
|
Skin and subcutaneous tissue disorders
Abscess on bottom
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Skin and subcutaneous tissue disorders
Bottom wound
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Skin and subcutaneous tissue disorders
Foot ulcer
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Skin and subcutaneous tissue disorders
Plantar wart right gr toe
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Skin and subcutaneous tissue disorders
Right foot wound
|
2.7%
1/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Skin and subcutaneous tissue disorders
Scalp sores
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Social circumstances
Bed bugs
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
3.3%
1/30 • Years 1-5
|
|
Surgical and medical procedures
PD catheter revision
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Surgical and medical procedures
Vascular Disorders
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Surgical and medical procedures
Poor circulation in left foot
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Surgical and medical procedures
Splenic artery aneurysm
|
0.00%
0/37 • Years 1-5
|
4.2%
1/24 • Years 1-5
|
0.00%
0/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
|
Surgical and medical procedures
Thrombosed AV fistula
|
0.00%
0/37 • Years 1-5
|
0.00%
0/24 • Years 1-5
|
2.0%
1/50 • Years 1-5
|
0.00%
0/30 • Years 1-5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place