Trial Outcomes & Findings for Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis (NCT NCT00503399)
NCT ID: NCT00503399
Last Updated: 2012-03-13
Results Overview
Least Squares (LS) Means were adjusted for age, baseline serum aminoterminal propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.
COMPLETED
PHASE3
92 participants
Baseline, 18 months
2012-03-13
Participant Flow
Of the 174 participants who were enrolled into the study, 92 were eligible and randomly assigned to the treatment arms.
Participant milestones
| Measure |
Teriparatide
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
47
|
|
Overall Study
COMPLETED
|
38
|
39
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
Teriparatide
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis
Baseline characteristics by cohort
| Measure |
Teriparatide
n=45 Participants
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
n=47 Participants
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.5 years
STANDARD_DEVIATION 12.80 • n=93 Participants
|
55.1 years
STANDARD_DEVIATION 15.54 • n=4 Participants
|
56.3 years
STANDARD_DEVIATION 14.24 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
44 participants
n=93 Participants
|
46 participants
n=4 Participants
|
90 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
19 participants
n=93 Participants
|
21 participants
n=4 Participants
|
40 participants
n=27 Participants
|
|
Region of Enrollment
Greece
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
5 participants
n=93 Participants
|
8 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
15 participants
n=93 Participants
|
12 participants
n=4 Participants
|
27 participants
n=27 Participants
|
|
Number of participants with fractures before study
With fractures
|
19 participants
n=93 Participants
|
17 participants
n=4 Participants
|
36 participants
n=27 Participants
|
|
Number of participants with fractures before study
Without fractures
|
26 participants
n=93 Participants
|
30 participants
n=4 Participants
|
56 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 18 monthsPopulation: The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit.
Least Squares (LS) Means were adjusted for age, baseline serum aminoterminal propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.
Outcome measures
| Measure |
Teriparatide
n=39 Participants
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
n=40 Participants
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
|---|---|---|
|
Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months
|
12.28 milligram per cubic centimeter (mg/cm^3)
Standard Error 3.16
|
2.94 milligram per cubic centimeter (mg/cm^3)
Standard Error 3.14
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit.
Least Squares (LS) Means were adjusted for age, baseline propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.
Outcome measures
| Measure |
Teriparatide
n=39 Participants
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
n=40 Participants
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
|---|---|---|
|
Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months
|
4.31 milligram per cubic centimeter (mg/cm^3)
Standard Error 3.15
|
2.52 milligram per cubic centimeter (mg/cm^3)
Standard Error 3.16
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 18 monthsPopulation: The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.
Three-dimensional (3-D) microstructure variables of T12 were assessed by HR-QCT. In contrast with regular QCT that assessed 3 millimeter (mm) slide thickness, HR-QCT used segmentation of 1 single vertebra with approximately 100 consecutive slides reconstructed at 300-400 micrometer (µm) slice increments covering the complete vertebral body. Least Squares (LS) Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.
Outcome measures
| Measure |
Teriparatide
n=39 Participants
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
n=40 Participants
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
|---|---|---|
|
Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months
Integral BMD at 6 months
|
-0.42 milligram per cubic centimeter (mg/cm^3)
Standard Error 6.42
|
-1.91 milligram per cubic centimeter (mg/cm^3)
Standard Error 7.11
|
|
Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months
Integral BMD at 18 months
|
10.72 milligram per cubic centimeter (mg/cm^3)
Standard Error 6.22
|
0.68 milligram per cubic centimeter (mg/cm^3)
Standard Error 7.08
|
|
Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months
Trabecular BMD at 6 months
|
-0.70 milligram per cubic centimeter (mg/cm^3)
Standard Error 5.26
|
-0.87 milligram per cubic centimeter (mg/cm^3)
Standard Error 5.85
|
|
Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months
Trabecular BMD at 18 months
|
9.53 milligram per cubic centimeter (mg/cm^3)
Standard Error 5.09
|
0.22 milligram per cubic centimeter (mg/cm^3)
Standard Error 5.82
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 18 monthsPopulation: The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.
Anterior bending and axial torsion were measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.
Outcome measures
| Measure |
Teriparatide
n=39 Participants
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
n=40 Participants
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
|---|---|---|
|
Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
Axial torsion strength at 6 months
|
6127.7 Newton/millimeter/radian (N/mm/rad)
Standard Error 4132.3
|
3664.0 Newton/millimeter/radian (N/mm/rad)
Standard Error 4233.5
|
|
Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
Anterior bending stiffness at 6 months
|
664969.0 Newton/millimeter/radian (N/mm/rad)
Standard Error 317684.0
|
415705.0 Newton/millimeter/radian (N/mm/rad)
Standard Error 323135.0
|
|
Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
Anterior bending stiffness at 18 months
|
1209225.0 Newton/millimeter/radian (N/mm/rad)
Standard Error 300977.0
|
233283.0 Newton/millimeter/radian (N/mm/rad)
Standard Error 322829.0
|
|
Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
Axial torsion stiffness at 6 months
|
142902.9 Newton/millimeter/radian (N/mm/rad)
Standard Error 71714.2
|
77830.7 Newton/millimeter/radian (N/mm/rad)
Standard Error 72947.9
|
|
Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
Axial torsion stiffness at 18 months
|
279392.8 Newton/millimeter/radian (N/mm/rad)
Standard Error 68284.5
|
56639.3 Newton/millimeter/radian (N/mm/rad)
Standard Error 72946.9
|
|
Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
Anterior bending strength at 6 months
|
12490.9 Newton/millimeter/radian (N/mm/rad)
Standard Error 8405.0
|
8827.2 Newton/millimeter/radian (N/mm/rad)
Standard Error 8741.0
|
|
Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
Anterior bending strength at 18 months
|
26046.4 Newton/millimeter/radian (N/mm/rad)
Standard Error 8304.1
|
4822.0 Newton/millimeter/radian (N/mm/rad)
Standard Error 8686.6
|
|
Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
Axial torsion strength at 18 months
|
14181.3 Newton/millimeter/radian (N/mm/rad)
Standard Error 3954.4
|
2545.8 Newton/millimeter/radian (N/mm/rad)
Standard Error 4228.7
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 18 monthsPopulation: The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.
Axial compression was measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated the strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.
Outcome measures
| Measure |
Teriparatide
n=39 Participants
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
n=40 Participants
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
|---|---|---|
|
Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
Axial compression strength at 6 months
|
580.7 Newton per millimeter (N/mm)
Standard Error 444.6
|
313.6 Newton per millimeter (N/mm)
Standard Error 457.0
|
|
Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
Axial compression stiffness at 6 months
|
890.7 Newton per millimeter (N/mm)
Standard Error 596.6
|
407.6 Newton per millimeter (N/mm)
Standard Error 607.6
|
|
Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
Axial compression stiffness at 18 months
|
1973.9 Newton per millimeter (N/mm)
Standard Error 569.0
|
363.7 Newton per millimeter (N/mm)
Standard Error 605.9
|
|
Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength
Axial compression strength at 18 months
|
1287.5 Newton per millimeter (N/mm)
Standard Error 424.0
|
209.4 Newton per millimeter (N/mm)
Standard Error 455.5
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.
Dual x-ray absorptiometry (DXA) techniques validated this measurement at skeletal sites that are at risk of osteoporotic fracture, such as lumbar spine, femoral neck, and hip.
Outcome measures
| Measure |
Teriparatide
n=45 Participants
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
n=47 Participants
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
|---|---|---|
|
Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months
Lumbar spine (n=38; n=39)
|
0.068 grams per square centimeter (g/cm^2)
Standard Deviation 0.0685
|
0.037 grams per square centimeter (g/cm^2)
Standard Deviation 0.0493
|
|
Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months
Hip (n=38; n=37)
|
0.014 grams per square centimeter (g/cm^2)
Standard Deviation 0.0319
|
0.007 grams per square centimeter (g/cm^2)
Standard Deviation 0.0320
|
|
Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months
Femoral neck (n=38; n=37)
|
0.014 grams per square centimeter (g/cm^2)
Standard Deviation 0.0446
|
-0.007 grams per square centimeter (g/cm^2)
Standard Deviation 0.0333
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 18 monthsPopulation: The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.
P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid.
Outcome measures
| Measure |
Teriparatide
n=45 Participants
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
n=47 Participants
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
|---|---|---|
|
Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months
P1NP at 3 months
|
27.33 micrograms per deciliter (μg/dL)
Standard Error 8.32
|
-16.09 micrograms per deciliter (μg/dL)
Standard Error 7.82
|
|
Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months
P1NP at 6 months
|
52.55 micrograms per deciliter (μg/dL)
Standard Error 8.27
|
-16.50 micrograms per deciliter (μg/dL)
Standard Error 7.95
|
|
Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months
P1NP at 18 months
|
28.48 micrograms per deciliter (μg/dL)
Standard Error 8.74
|
-15.58 micrograms per deciliter (μg/dL)
Standard Error 8.58
|
SECONDARY outcome
Timeframe: 3, 6, 18 monthsPopulation: The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.
β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix.
Outcome measures
| Measure |
Teriparatide
n=45 Participants
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
n=47 Participants
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
|---|---|---|
|
Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months
β-CTx at 3 months
|
0.12 nanograms per deciliter (ng/dL)
Standard Error 0.07
|
-0.15 nanograms per deciliter (ng/dL)
Standard Error 0.07
|
|
Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months
β-CTx at 6 months
|
0.25 nanograms per deciliter (ng/dL)
Standard Error 0.07
|
-0.14 nanograms per deciliter (ng/dL)
Standard Error 0.07
|
|
Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months
β-CTx at 18 months
|
0.03 nanograms per deciliter (ng/dL)
Standard Error 0.08
|
-0.11 nanograms per deciliter (ng/dL)
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline up to 18 monthsPopulation: The safety analysis set included all participants who received study treatment.
Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. Fractures that occurred during the study were collected separately as an additional safety variable. The number of participants experiencing hypercalcemia was summarized for each treatment arm. Hypercalcemia was defined as a serum calcium level corrected for albumin of \>2.7 millimole per liter (mmol/L) (10.8 milligram per deciliter \[mg/dL\]).
Outcome measures
| Measure |
Teriparatide
n=45 Participants
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
n=47 Participants
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Serious Adverse Events (SAEs)
|
13 participants
|
22 participants
|
|
Number of Participants With Adverse Events (AEs)
Other Non-serious AEs
|
22 participants
|
30 participants
|
|
Number of Participants With Adverse Events (AEs)
Fractures
|
0 participants
|
5 participants
|
|
Number of Participants With Adverse Events (AEs)
Hypercalcemia
|
0 participants
|
0 participants
|
Adverse Events
Teriparatide
Risedronate
Serious adverse events
| Measure |
Teriparatide
n=45 participants at risk
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
n=47 participants at risk
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
1/45 • Number of events 1
|
0.00%
0/47
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Cardiac disorders
Aortic valve incompetence
|
2.2%
1/45 • Number of events 1
|
0.00%
0/47
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Eye disorders
Cataract
|
2.2%
1/45 • Number of events 1
|
0.00%
0/47
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/45
|
2.1%
1/47 • Number of events 2
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/45
|
4.3%
2/47 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.2%
1/45 • Number of events 1
|
0.00%
0/47
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
General disorders
Sudden death
|
2.2%
1/45 • Number of events 1
|
0.00%
0/47
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Infections and infestations
Anal abscess
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Infections and infestations
Cytomegalovirus infection
|
2.2%
1/45 • Number of events 1
|
0.00%
0/47
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/45
|
4.3%
2/47 • Number of events 2
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.2%
1/45 • Number of events 1
|
0.00%
0/47
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/45
|
2.1%
1/47 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
6.7%
3/45 • Number of events 3
|
0.00%
0/47
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.2%
1/45 • Number of events 1
|
0.00%
0/47
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.2%
1/45 • Number of events 1
|
0.00%
0/47
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.4%
2/45 • Number of events 2
|
6.4%
3/47 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
1/45 • Number of events 1
|
0.00%
0/47
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
2.2%
1/45 • Number of events 1
|
0.00%
0/47
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/45
|
2.1%
1/47 • Number of events 1
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/45
|
4.3%
2/47 • Number of events 3
|
Other adverse events
| Measure |
Teriparatide
n=45 participants at risk
Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
|
Risedronate
n=47 participants at risk
Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/45
|
4.3%
2/47 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/45 • Number of events 1
|
4.3%
2/47 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/45 • Number of events 1
|
6.4%
3/47 • Number of events 3
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
2.2%
1/45 • Number of events 1
|
4.3%
2/47 • Number of events 2
|
|
General disorders
Oedema peripheral
|
6.7%
3/45 • Number of events 4
|
4.3%
2/47 • Number of events 2
|
|
Hepatobiliary disorders
Cholelithiasis
|
4.4%
2/45 • Number of events 2
|
0.00%
0/47
|
|
Infections and infestations
Influenza
|
8.9%
4/45 • Number of events 4
|
6.4%
3/47 • Number of events 4
|
|
Infections and infestations
Lung infection
|
0.00%
0/45
|
4.3%
2/47 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
2/45 • Number of events 2
|
4.3%
2/47 • Number of events 2
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/45
|
4.3%
2/47 • Number of events 4
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/45
|
4.3%
2/47 • Number of events 2
|
|
Investigations
Weight decreased
|
0.00%
0/45
|
4.3%
2/47 • Number of events 2
|
|
Investigations
Weight increased
|
2.2%
1/45 • Number of events 1
|
6.4%
3/47 • Number of events 3
|
|
Metabolism and nutrition disorders
Obesity
|
4.4%
2/45 • Number of events 2
|
0.00%
0/47
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
4/45 • Number of events 4
|
6.4%
3/47 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
3/45 • Number of events 3
|
0.00%
0/47
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/45 • Number of events 1
|
4.3%
2/47 • Number of events 2
|
|
Nervous system disorders
Headache
|
2.2%
1/45 • Number of events 1
|
4.3%
2/47 • Number of events 3
|
|
Nervous system disorders
Paraesthesia
|
4.4%
2/45 • Number of events 2
|
0.00%
0/47
|
|
Psychiatric disorders
Insomnia
|
4.4%
2/45 • Number of events 2
|
0.00%
0/47
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/45
|
6.4%
3/47 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.4%
2/45 • Number of events 2
|
0.00%
0/47
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/45
|
4.3%
2/47 • Number of events 2
|
|
Surgical and medical procedures
Cataract operation
|
4.4%
2/45 • Number of events 2
|
2.1%
1/47 • Number of events 2
|
|
Vascular disorders
Haematoma
|
0.00%
0/45
|
4.3%
2/47 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60