Trial Outcomes & Findings for VERtebral Fracture Treatment Comparisons in Osteoporotic Women (NCT NCT01709110)
NCT ID: NCT01709110
Last Updated: 2019-09-23
Results Overview
The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation. A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1366 participants
Primary outcome timeframe
Baseline through 24 Months
Results posted on
2019-09-23
Participant Flow
Participant milestones
| Measure |
Teriparatide
Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
Risedronate 35 milligram (mg) administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Overall Study
STARTED
|
683
|
683
|
|
Overall Study
Received at Least One Dose of Study Drug
|
680
|
680
|
|
Overall Study
COMPLETED
|
498
|
515
|
|
Overall Study
NOT COMPLETED
|
185
|
168
|
Reasons for withdrawal
| Measure |
Teriparatide
Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
Risedronate 35 milligram (mg) administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
56
|
48
|
|
Overall Study
Death
|
14
|
6
|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
|
Overall Study
Protocol Violation
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
96
|
89
|
|
Overall Study
Physician Decision
|
4
|
10
|
|
Overall Study
Sponsor Decision
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Caregiver Decision
|
1
|
1
|
Baseline Characteristics
Any lumbar vertebrae that were not analyzed due to artifacts, fracture, osteophytes, or other abnormalities, should be excluded from the analysis.
Baseline characteristics by cohort
| Measure |
Teriparatide
n=680 Participants
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=680 Participants
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
Total
n=1360 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.6 years
STANDARD_DEVIATION 8.77 • n=680 Participants
|
71.6 years
STANDARD_DEVIATION 8.58 • n=680 Participants
|
72.1 years
STANDARD_DEVIATION 8.68 • n=1360 Participants
|
|
Sex: Female, Male
Female
|
680 Participants
n=680 Participants
|
680 Participants
n=680 Participants
|
1360 Participants
n=1360 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=680 Participants
|
0 Participants
n=680 Participants
|
0 Participants
n=1360 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
104 Participants
n=680 Participants
|
99 Participants
n=680 Participants
|
203 Participants
n=1360 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
310 Participants
n=680 Participants
|
302 Participants
n=680 Participants
|
612 Participants
n=1360 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
266 Participants
n=680 Participants
|
279 Participants
n=680 Participants
|
545 Participants
n=1360 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=680 Participants
|
1 Participants
n=680 Participants
|
2 Participants
n=1360 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=680 Participants
|
8 Participants
n=680 Participants
|
12 Participants
n=1360 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=680 Participants
|
0 Participants
n=680 Participants
|
0 Participants
n=1360 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=680 Participants
|
15 Participants
n=680 Participants
|
20 Participants
n=1360 Participants
|
|
Race (NIH/OMB)
White
|
670 Participants
n=680 Participants
|
653 Participants
n=680 Participants
|
1323 Participants
n=1360 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=680 Participants
|
3 Participants
n=680 Participants
|
3 Participants
n=1360 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=680 Participants
|
0 Participants
n=680 Participants
|
0 Participants
n=1360 Participants
|
|
Region of Enrollment
Argentina
|
79 Participants
n=680 Participants
|
78 Participants
n=680 Participants
|
157 Participants
n=1360 Participants
|
|
Region of Enrollment
Hungary
|
68 Participants
n=680 Participants
|
53 Participants
n=680 Participants
|
121 Participants
n=1360 Participants
|
|
Region of Enrollment
Czech Republic
|
68 Participants
n=680 Participants
|
68 Participants
n=680 Participants
|
136 Participants
n=1360 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=680 Participants
|
67 Participants
n=680 Participants
|
122 Participants
n=1360 Participants
|
|
Region of Enrollment
Spain
|
66 Participants
n=680 Participants
|
55 Participants
n=680 Participants
|
121 Participants
n=1360 Participants
|
|
Region of Enrollment
Greece
|
27 Participants
n=680 Participants
|
13 Participants
n=680 Participants
|
40 Participants
n=1360 Participants
|
|
Region of Enrollment
Canada
|
36 Participants
n=680 Participants
|
33 Participants
n=680 Participants
|
69 Participants
n=1360 Participants
|
|
Region of Enrollment
Austria
|
24 Participants
n=680 Participants
|
29 Participants
n=680 Participants
|
53 Participants
n=1360 Participants
|
|
Region of Enrollment
Belgium
|
43 Participants
n=680 Participants
|
45 Participants
n=680 Participants
|
88 Participants
n=1360 Participants
|
|
Region of Enrollment
Poland
|
55 Participants
n=680 Participants
|
63 Participants
n=680 Participants
|
118 Participants
n=1360 Participants
|
|
Region of Enrollment
Brazil
|
63 Participants
n=680 Participants
|
81 Participants
n=680 Participants
|
144 Participants
n=1360 Participants
|
|
Region of Enrollment
Italy
|
33 Participants
n=680 Participants
|
36 Participants
n=680 Participants
|
69 Participants
n=1360 Participants
|
|
Region of Enrollment
France
|
26 Participants
n=680 Participants
|
29 Participants
n=680 Participants
|
55 Participants
n=1360 Participants
|
|
Region of Enrollment
Germany
|
37 Participants
n=680 Participants
|
30 Participants
n=680 Participants
|
67 Participants
n=1360 Participants
|
|
Distribution of Stratification Factors
Vertebral Fracture with Bisphosphonate Use
|
82 Participants
n=680 Participants
|
79 Participants
n=680 Participants
|
161 Participants
n=1360 Participants
|
|
Distribution of Stratification Factors
With Vertebral Fracture without Bisphosphonate Use
|
170 Participants
n=680 Participants
|
165 Participants
n=680 Participants
|
335 Participants
n=1360 Participants
|
|
Distribution of Stratification Factors
Without Vertebral Fracture with Bisphosphonate Use
|
184 Participants
n=680 Participants
|
189 Participants
n=680 Participants
|
373 Participants
n=1360 Participants
|
|
Distribution of Stratification Factors
Without Vertebral Fracture without Bisphosphonate
|
244 Participants
n=680 Participants
|
247 Participants
n=680 Participants
|
491 Participants
n=1360 Participants
|
|
Bone Mineral Density (BMD)
Lumbar Spine
|
0.858 Gram per square centimeter (g/cm2)
STANDARD_DEVIATION 0.1541 • n=644 Participants • Any lumbar vertebrae that were not analyzed due to artifacts, fracture, osteophytes, or other abnormalities, should be excluded from the analysis.
|
0.856 Gram per square centimeter (g/cm2)
STANDARD_DEVIATION 0.1473 • n=653 Participants • Any lumbar vertebrae that were not analyzed due to artifacts, fracture, osteophytes, or other abnormalities, should be excluded from the analysis.
|
0.857 Gram per square centimeter (g/cm2)
STANDARD_DEVIATION 0.1506 • n=1297 Participants • Any lumbar vertebrae that were not analyzed due to artifacts, fracture, osteophytes, or other abnormalities, should be excluded from the analysis.
|
|
Bone Mineral Density (BMD)
Femoral Neck
|
0.662 Gram per square centimeter (g/cm2)
STANDARD_DEVIATION 0.1085 • n=658 Participants • Any lumbar vertebrae that were not analyzed due to artifacts, fracture, osteophytes, or other abnormalities, should be excluded from the analysis.
|
0.667 Gram per square centimeter (g/cm2)
STANDARD_DEVIATION 0.1129 • n=656 Participants • Any lumbar vertebrae that were not analyzed due to artifacts, fracture, osteophytes, or other abnormalities, should be excluded from the analysis.
|
0.664 Gram per square centimeter (g/cm2)
STANDARD_DEVIATION 0.1107 • n=1314 Participants • Any lumbar vertebrae that were not analyzed due to artifacts, fracture, osteophytes, or other abnormalities, should be excluded from the analysis.
|
|
Bone Mineral Density (BMD)
Total Hip
|
0.736 Gram per square centimeter (g/cm2)
STANDARD_DEVIATION 0.1065 • n=633 Participants • Any lumbar vertebrae that were not analyzed due to artifacts, fracture, osteophytes, or other abnormalities, should be excluded from the analysis.
|
0.735 Gram per square centimeter (g/cm2)
STANDARD_DEVIATION 0.1165 • n=640 Participants • Any lumbar vertebrae that were not analyzed due to artifacts, fracture, osteophytes, or other abnormalities, should be excluded from the analysis.
|
0.735 Gram per square centimeter (g/cm2)
STANDARD_DEVIATION 0.1116 • n=1273 Participants • Any lumbar vertebrae that were not analyzed due to artifacts, fracture, osteophytes, or other abnormalities, should be excluded from the analysis.
|
|
Vertebral Fracture Status
1 Fracture
|
231 Participants
n=680 Participants
|
240 Participants
n=680 Participants
|
471 Participants
n=1360 Participants
|
|
Vertebral Fracture Status
2 Fractures
|
178 Participants
n=680 Participants
|
174 Participants
n=680 Participants
|
352 Participants
n=1360 Participants
|
|
Vertebral Fracture Status
3 Fractures
|
104 Participants
n=680 Participants
|
101 Participants
n=680 Participants
|
205 Participants
n=1360 Participants
|
|
Vertebral Fracture Status
4 Fractures
|
60 Participants
n=680 Participants
|
62 Participants
n=680 Participants
|
122 Participants
n=1360 Participants
|
|
Vertebral Fracture Status
5 or More Fractures
|
106 Participants
n=680 Participants
|
102 Participants
n=680 Participants
|
208 Participants
n=1360 Participants
|
PRIMARY outcome
Timeframe: Baseline through 24 MonthsPopulation: Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.
The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation. A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture.
Outcome measures
| Measure |
Teriparatide
n=516 Participants
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=533 Participants
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Proportion of Participants With New Vertebral Fractures
|
28 Participants (with at least one event)
|
64 Participants (with at least one event)
|
SECONDARY outcome
Timeframe: Baseline through 24 MonthsPopulation: Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.
Worsening of a pre-existing fracture was considered if the decrease in vertebral height was at least one severity grade in the semi-quantitative assessment, confirmed by a trained central reader, where vertebrae were graded as normal (SQ0) or as with mild (SQ1), moderate (SQ2), or severe (SQ3) fractures, defined as \~20 to 25% (mild), \~25 to 40% (moderate) or \~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 to L4).
Outcome measures
| Measure |
Teriparatide
n=516 Participants
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=533 Participants
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Proportion of Participants With Pooled New and Worsening Vertebral Fractures
|
31 Participants (with at least one event)
|
69 Participants (with at least one event)
|
SECONDARY outcome
Timeframe: Baseline through 24 MonthsPopulation: Full analysis set: all participants who received at least one dose of study drug and had evaluable data.
A clinical vertebral fracture was defined as a new or worsening vertebral fracture, confirmed by radiography, that was associated with signs and symptoms highly suggestive of a vertebral fracture. All non-vertebral fractures that occurred and were diagnosed between visits required the confirmation by the site investigators after evaluating the original x-ray film(s), the radiology or surgical report. For clinical vertebral fractures, the final confirmation of the diagnosis required the centralized evaluation by a trained, independent reader.
Outcome measures
| Measure |
Teriparatide
n=680 Participants
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=680 Participants
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures
|
30 Participants (with at least one event)
|
61 Participants (with at least one event)
|
SECONDARY outcome
Timeframe: Baseline through 24 MonthsPopulation: Full analysis set: all participants who received at least one dose of study drug and had evaluable data.
A non-vertebral fracture is a fracture at any of the following non-vertebral sites: clavicle, scapula, ribs, sternum, sacrum, coccyx, humerus, radius, ulna, carpus, pelvis, hip, femur, patella, tibia, fibula, ankle, calcaneus, tarsus, and metatarsal. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object were not considered fragility fractures but traumatic fractures.
Outcome measures
| Measure |
Teriparatide
n=680 Participants
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=680 Participants
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Proportion of Participants With Non-Vertebral Fragility Fractures
|
25 Participants (with at least one event)
|
38 Participants (with at least one event)
|
SECONDARY outcome
Timeframe: Baseline through 24 MonthsPopulation: Full analysis set: all participants who received at least one dose of study drug and had evaluable data.
A major non-vertebral fracture is a fracture at any of the following non-vertebral sites hip, radius, humerus, ribs, pelvis, tibia and femur. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving.
Outcome measures
| Measure |
Teriparatide
n=680 Participants
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=680 Participants
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Proportion of Participants With Major Non-Vertebral Fragility Fractures
|
18 Participants (with at least one event)
|
31 Participants (with at least one event)
|
SECONDARY outcome
Timeframe: Baseline through 24 MonthsPopulation: Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.
Vertebrae were graded as moderate (SQ2), or severe (SQ3) fractures, based on \~25 to 40% (moderate) or \~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 through L4).
Outcome measures
| Measure |
Teriparatide
n=516 Participants
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=533 Participants
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Proportion of Participants With New Moderate and/or Severe Vertebral Fractures
|
26 Participants (with at least one event)
|
63 Participants (with at least one event)
|
SECONDARY outcome
Timeframe: Baseline through 24 MonthsPopulation: Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.
Outcome measures
| Measure |
Teriparatide
n=516 Participants
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=533 Participants
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Proportion of Participants With New Multiple (2 or More) Vertebral Fractures
|
2 Participants (with at least one event)
|
12 Participants (with at least one event)
|
SECONDARY outcome
Timeframe: Baseline through 24 MonthsPopulation: Full analysis set: all participants who received at least one dose of study drug and had evaluable data.
Traumatic fractures were considered if resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object.
Outcome measures
| Measure |
Teriparatide
n=680 Participants
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=680 Participants
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures
|
40 Participants (with at least one event)
|
57 Participants (with at least one event)
|
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Full analysis set: all participants who received at least one dose of study drug and had evaluable data.
Outcome measures
| Measure |
Teriparatide
n=565 Participants
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=580 Participants
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Change From Baseline to 24 Months Endpoint in Height
Baseline
|
154.7 Centimeter (cm)
Standard Deviation 7.15
|
155.0 Centimeter (cm)
Standard Deviation 7.40
|
|
Change From Baseline to 24 Months Endpoint in Height
24 Months
|
154.3 Centimeter (cm)
Standard Deviation 7.05
|
154.5 Centimeter (cm)
Standard Deviation 7.42
|
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Full analysis set: all participants who received at least one dose of study drug and had evaluable data.
Participants rated the worst back pain during the 24 hours preceding the visit at baseline and each post-baseline visit. An 11-point numerical back pain rating scale (rated from 0 = no back pain to 10 = worst possible back pain) was used.
Outcome measures
| Measure |
Teriparatide
n=642 Participants
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=648 Participants
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale
Baseline
|
4.5 units on a scale
Standard Deviation 2.90
|
4.5 units on a scale
Standard Deviation 2.91
|
|
Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale
24 Months
|
3.4 units on a scale
Standard Deviation 2.95
|
3.4 units on a scale
Standard Deviation 2.89
|
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Full analysis set: all participants who received at least one dose of study drug and had evaluable data.
The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.59 to 1.0. A higher score indicates better health state.
Outcome measures
| Measure |
Teriparatide
n=642 Participants
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=647 Participants
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)
Baseline
|
0.59 units on a scale
Standard Deviation 0.243
|
0.62 units on a scale
Standard Deviation 0.228
|
|
Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)
24 Months
|
0.65 units on a scale
Standard Deviation 0.249
|
0.68 units on a scale
Standard Deviation 0.205
|
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Full analysis set: all participants who received at least one dose of study drug and had evaluable data.
The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United States (US) cross walk algorithm, with scores ranging from -0.11 to 1.0. A higher score indicates better health state.
Outcome measures
| Measure |
Teriparatide
n=642 Participants
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=647 Participants
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)
Baseline
|
0.70 units on a scale
Standard Deviation 0.167
|
0.72 units on a scale
Standard Deviation 0.159
|
|
Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)
24 Months
|
0.74 units on a scale
Standard Deviation 0.176
|
0.76 units on a scale
Standard Deviation 0.145
|
Adverse Events
Teriparatide
Serious events: 138 serious events
Other events: 130 other events
Deaths: 0 deaths
Risedronate
Serious events: 117 serious events
Other events: 130 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teriparatide
n=683 participants at risk
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=683 participants at risk
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.15%
1/683 • Number of events 1
|
0.15%
1/683 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.15%
1/683 • Number of events 1
|
0.15%
1/683 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.29%
2/683 • Number of events 2
|
0.00%
0/683
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.15%
1/683 • Number of events 1
|
0.29%
2/683 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.44%
3/683 • Number of events 3
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondrosarcoma
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cystadenocarcinoma ovary
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.15%
1/683 • Number of events 1
|
0.15%
1/683 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.29%
2/683 • Number of events 2
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.15%
1/683 • Number of events 1
|
0.29%
2/683 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Nervous system disorders
Carotid artery stenosis
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.29%
2/683 • Number of events 2
|
0.15%
1/683 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Nervous system disorders
Embolic stroke
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Psychiatric disorders
Confusional state
|
0.15%
1/683 • Number of events 1
|
0.15%
1/683 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Psychiatric disorders
Major depression
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Renal and urinary disorders
Acute kidney injury
|
0.29%
2/683 • Number of events 2
|
0.15%
1/683 • Number of events 1
|
|
Renal and urinary disorders
Calculus urinary
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/683
|
0.29%
2/683 • Number of events 2
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Renal and urinary disorders
Renal impairment
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.15%
1/683 • Number of events 1
|
0.15%
1/683 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.15%
1/683 • Number of events 1
|
0.29%
2/683 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.15%
1/683 • Number of events 1
|
0.29%
2/683 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.29%
2/683 • Number of events 2
|
0.15%
1/683 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.15%
1/683 • Number of events 1
|
0.15%
1/683 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.44%
3/683 • Number of events 3
|
0.15%
1/683 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.29%
2/683 • Number of events 2
|
0.15%
1/683 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Vascular disorders
Aortic aneurysm
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Vascular disorders
Aortic stenosis
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Vascular disorders
Arterial disorder
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Vascular disorders
Deep vein thrombosis
|
0.29%
2/683 • Number of events 2
|
0.44%
3/683 • Number of events 3
|
|
Vascular disorders
Granulomatosis with polyangiitis
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Vascular disorders
Hypertension
|
0.15%
1/683 • Number of events 1
|
0.29%
2/683 • Number of events 2
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/683
|
0.29%
2/683 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.59%
4/683 • Number of events 4
|
0.00%
0/683
|
|
Vascular disorders
Peripheral artery occlusion
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Vascular disorders
Subclavian artery occlusion
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Nervous system disorders
Intercostal neuralgia
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Nervous system disorders
Ischaemic stroke
|
0.29%
2/683 • Number of events 2
|
0.44%
3/683 • Number of events 3
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Nervous system disorders
Radicular pain
|
0.15%
1/683 • Number of events 1
|
0.15%
1/683 • Number of events 1
|
|
Nervous system disorders
Radiculopathy
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Nervous system disorders
Sciatica
|
0.29%
2/683 • Number of events 2
|
0.00%
0/683
|
|
Nervous system disorders
Spinal cord compression
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Nervous system disorders
Syncope
|
0.44%
3/683 • Number of events 3
|
0.29%
2/683 • Number of events 2
|
|
Nervous system disorders
Transient ischaemic attack
|
0.29%
2/683 • Number of events 2
|
0.29%
2/683 • Number of events 2
|
|
Nervous system disorders
Tremor
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Nervous system disorders
Vascular dementia
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Nervous system disorders
Vascular encephalopathy
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Product Issues
Device dislocation
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Product Issues
Device malfunction
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Psychiatric disorders
Alcohol abuse
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Infections and infestations
Clostridium difficile infection
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Infections and infestations
Diverticulitis
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Infections and infestations
Erysipelas
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.29%
2/683 • Number of events 2
|
0.44%
3/683 • Number of events 3
|
|
Infections and infestations
Gastroenteritis viral
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Infections and infestations
Peritonitis
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Infections and infestations
Pneumonia
|
0.44%
3/683 • Number of events 3
|
0.44%
3/683 • Number of events 3
|
|
Infections and infestations
Postoperative wound infection
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Infections and infestations
Pyelonephritis acute
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Infections and infestations
Pyonephrosis
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.15%
1/683 • Number of events 1
|
0.15%
1/683 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.29%
2/683 • Number of events 3
|
0.15%
1/683 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Concussion
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/683
|
0.29%
2/683 • Number of events 2
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.29%
2/683 • Number of events 2
|
0.15%
1/683 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
15/683 • Number of events 16
|
2.8%
19/683 • Number of events 21
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.59%
4/683 • Number of events 4
|
0.44%
3/683 • Number of events 3
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.44%
3/683 • Number of events 4
|
0.88%
6/683 • Number of events 7
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/683
|
0.29%
2/683 • Number of events 2
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.15%
1/683 • Number of events 1
|
0.15%
1/683 • Number of events 1
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.15%
1/683 • Number of events 1
|
0.73%
5/683 • Number of events 5
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.44%
3/683 • Number of events 3
|
0.73%
5/683 • Number of events 5
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.44%
3/683 • Number of events 4
|
0.88%
6/683 • Number of events 6
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/683
|
0.44%
3/683 • Number of events 3
|
|
Injury, poisoning and procedural complications
Post procedural stroke
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.29%
2/683 • Number of events 2
|
0.29%
2/683 • Number of events 2
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.44%
3/683 • Number of events 4
|
0.15%
1/683 • Number of events 3
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/683
|
0.29%
2/683 • Number of events 2
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.29%
2/683 • Number of events 6
|
0.44%
3/683 • Number of events 4
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.15%
1/683 • Number of events 1
|
0.44%
3/683 • Number of events 3
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.15%
1/683 • Number of events 1
|
0.15%
1/683 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Investigations
Carbohydrate antigen 19-9 increased
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Investigations
General physical condition abnormal
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Investigations
Weight decreased
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/683
|
0.29%
2/683 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.44%
3/683 • Number of events 3
|
0.73%
5/683 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.44%
3/683 • Number of events 3
|
0.59%
4/683 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Metabolism and nutrition disorders
Dehydration
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/683
|
0.15%
1/683 • Number of events 2
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.29%
2/683 • Number of events 2
|
0.00%
0/683
|
|
Cardiac disorders
Acute myocardial infarction
|
0.44%
3/683 • Number of events 3
|
0.15%
1/683 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.73%
5/683 • Number of events 5
|
0.44%
3/683 • Number of events 3
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/683
|
0.29%
2/683 • Number of events 2
|
|
Cardiac disorders
Cardiac arrest
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Cardiac disorders
Cardiac failure
|
0.29%
2/683 • Number of events 2
|
0.29%
2/683 • Number of events 2
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Cardiac disorders
Cardiac valve disease
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Cardiac disorders
Mitral valve incompetence
|
0.15%
1/683 • Number of events 1
|
0.15%
1/683 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.29%
2/683 • Number of events 2
|
0.15%
1/683 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Congenital, familial and genetic disorders
Left ventricle outflow tract obstruction
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Endocrine disorders
Goitre
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/683
|
0.44%
3/683 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Gastrointestinal disorders
Diverticulum
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Gastrointestinal disorders
Enteritis
|
0.29%
2/683 • Number of events 2
|
0.00%
0/683
|
|
Gastrointestinal disorders
Enterocolitis
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.15%
1/683 • Number of events 1
|
0.15%
1/683 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.15%
1/683 • Number of events 1
|
0.15%
1/683 • Number of events 1
|
|
Gastrointestinal disorders
Regurgitation
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
General disorders
Asthenia
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
General disorders
Death
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.15%
1/683 • Number of events 2
|
0.00%
0/683
|
|
General disorders
Performance status decreased
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
General disorders
Sudden cardiac death
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Hepatobiliary disorders
Biliary colic
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/683
|
0.29%
2/683 • Number of events 2
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/683
|
0.15%
1/683 • Number of events 1
|
|
Infections and infestations
Abdominal sepsis
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
|
Infections and infestations
Appendicitis
|
0.44%
3/683 • Number of events 3
|
0.00%
0/683
|
|
Infections and infestations
Cellulitis
|
0.15%
1/683 • Number of events 1
|
0.00%
0/683
|
Other adverse events
| Measure |
Teriparatide
n=683 participants at risk
Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
|
Risedronate
n=683 participants at risk
Risedronate 35 milligram administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
44/683 • Number of events 54
|
7.5%
51/683 • Number of events 63
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.7%
73/683 • Number of events 77
|
11.6%
79/683 • Number of events 89
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
37/683 • Number of events 45
|
0.00%
0/683
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60