Trial Outcomes & Findings for An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women (NCT NCT01796301)
NCT ID: NCT01796301
Last Updated: 2022-11-29
Results Overview
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
436 participants
Primary outcome timeframe
Baseline, month 6 and month 12
Results posted on
2022-11-29
Participant Flow
The study was conducted at 46 sites in North America, Latin America, and Europe. Participants were enrolled from 31 January 2013 to 29 April 2014.
A total of 777 subjects were screened for participation; 341 (43.9%) were excluded prior to randomization, primarily due to not meeting inclusion/exclusion criteria (306 \[39.4%\] subjects). A total of 436 participants were randomized into the study.
Participant milestones
| Measure |
Teriparatide
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
218
|
218
|
|
Overall Study
Received Treatment
|
214
|
218
|
|
Overall Study
COMPLETED
|
200
|
198
|
|
Overall Study
NOT COMPLETED
|
18
|
20
|
Reasons for withdrawal
| Measure |
Teriparatide
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
15
|
15
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Decision by Sponsor
|
0
|
1
|
Baseline Characteristics
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Teriparatide
n=218 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=218 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Total
n=436 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.2 years
STANDARD_DEVIATION 7.7 • n=99 Participants
|
71.8 years
STANDARD_DEVIATION 7.4 • n=107 Participants
|
71.5 years
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Age, Customized
< 65 years
|
48 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Age, Customized
≥ 65 to < 75 years
|
96 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
179 Participants
n=206 Participants
|
|
Age, Customized
≥ 75 years
|
74 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
218 Participants
n=99 Participants
|
218 Participants
n=107 Participants
|
436 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
196 Participants
n=99 Participants
|
191 Participants
n=107 Participants
|
387 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
18 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Prior Fracture
Yes
|
217 Participants
n=99 Participants
|
218 Participants
n=107 Participants
|
435 Participants
n=206 Participants
|
|
Prior Fracture
No
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Lumbar Spine BMD T-score
|
-2.87 T-score
STANDARD_DEVIATION 1.04 • n=99 Participants
|
-2.83 T-score
STANDARD_DEVIATION 1.10 • n=107 Participants
|
-2.85 T-score
STANDARD_DEVIATION 1.07 • n=206 Participants
|
|
Total Hip BMD T-score
|
-2.21 T-score
STANDARD_DEVIATION 0.72 • n=99 Participants
|
-2.27 T-score
STANDARD_DEVIATION 0.75 • n=107 Participants
|
-2.24 T-score
STANDARD_DEVIATION 0.74 • n=206 Participants
|
|
Femoral Neck BMD T-score
|
-2.43 T-score
STANDARD_DEVIATION 0.66 • n=99 Participants
|
-2.49 T-score
STANDARD_DEVIATION 0.67 • n=107 Participants
|
-2.46 T-score
STANDARD_DEVIATION 0.66 • n=206 Participants
|
|
Serum Type 1 Collagen C-telopeptide (sCTX)
|
260.1 ng/L
STANDARD_DEVIATION 124.9 • n=99 Participants
|
252.3 ng/L
STANDARD_DEVIATION 136.4 • n=107 Participants
|
256.2 ng/L
STANDARD_DEVIATION 130.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, month 6 and month 12Population: The primary efficacy analysis set includes randomized participants with a non-missing baseline and at least one post-baseline measurement.
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12.
Outcome measures
| Measure |
Teriparatide
n=209 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=206 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)
|
-0.6 percent change
Standard Error 0.2
|
2.6 percent change
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: The primary efficacy analysis set with values at baseline and month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Outcome measures
| Measure |
Teriparatide
n=203 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=203 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Total Hip BMD at Month 6
|
-0.8 percent change
Standard Error 0.2
|
2.3 percent change
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: The primary efficacy analysis set with values at baseline and month 12
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Outcome measures
| Measure |
Teriparatide
n=202 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=197 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Total Hip BMD at Month 12
|
-0.5 percent change
Standard Error 0.2
|
2.9 percent change
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: The primary efficacy analysis set with values at baseline and month 6
Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.
Outcome measures
| Measure |
Teriparatide
n=156 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=163 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6
|
-2.7 percent change
Standard Error 0.2
|
0.7 percent change
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: The primary efficacy analysis set with values at baseline and month 12
Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.
Outcome measures
| Measure |
Teriparatide
n=159 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=163 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12
|
-3.6 percent change
Standard Error 0.3
|
1.1 percent change
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: The primary efficacy analysis set with values at baseline and month 6
Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.
Outcome measures
| Measure |
Teriparatide
n=156 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=163 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6
|
-0.8 percent change
Standard Error 0.2
|
2.3 percent change
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: The primary efficacy analysis set with values at baseline and month 12
Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.
Outcome measures
| Measure |
Teriparatide
n=159 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=163 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12
|
-0.2 percent change
Standard Error 0.2
|
3.4 percent change
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: The primary efficacy analysis set with values at baseline and month 6
Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.
Outcome measures
| Measure |
Teriparatide
n=163 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=164 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6
|
-1.0 percent change
Standard Error 0.2
|
2.1 percent change
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: The primary efficacy analysis set with values at baseline and month 12
Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.
Outcome measures
| Measure |
Teriparatide
n=155 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=159 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12
|
-0.7 percent change
Standard Error 0.4
|
2.5 percent change
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: The primary efficacy analysis set with values at baseline and month 6
Total hip integral BMC was measured using quantitative computed tomography (QCT).
Outcome measures
| Measure |
Teriparatide
n=156 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=163 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6
|
-0.7 percent change
Standard Error 0.2
|
2.4 percent change
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: The primary efficacy analysis set with values at baseline and month 12
Total hip integral BMC was measured using quantitative computed tomography (QCT).
Outcome measures
| Measure |
Teriparatide
n=159 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=163 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12
|
0.0 percent change
Standard Error 0.2
|
3.6 percent change
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: The primary efficacy analysis set with values at baseline and month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Outcome measures
| Measure |
Teriparatide
n=203 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=203 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD at Month 6
|
-1.1 percent change
Standard Error 0.3
|
2.1 percent change
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: The primary efficacy analysis set with values at baseline and month 12
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Outcome measures
| Measure |
Teriparatide
n=202 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=197 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD at Month 12
|
-0.2 percent change
Standard Error 0.3
|
3.2 percent change
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: The primary efficacy analysis set with values at baseline and month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Outcome measures
| Measure |
Teriparatide
n=204 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=203 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD at Month 6
|
3.5 percent change
Standard Error 0.3
|
7.2 percent change
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: The primary efficacy analysis set with values at baseline and month 12
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Outcome measures
| Measure |
Teriparatide
n=201 Participants
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=197 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD at Month 12
|
5.4 percent change
Standard Error 0.4
|
9.8 percent change
Standard Error 0.4
|
Adverse Events
Teriparatide
Serious events: 23 serious events
Other events: 76 other events
Deaths: 0 deaths
Romosozumab
Serious events: 17 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teriparatide
n=214 participants at risk
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=218 participants at risk
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
2/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Bifascicular block
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Sinus bradycardia
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.93%
2/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Appendicitis
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diverticulitis
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.93%
2/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia bacterial
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign soft tissue neoplasm
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage III
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Radicular pain
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Radicular syndrome
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Seizure
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.47%
1/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.00%
0/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.46%
1/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Teriparatide
n=214 participants at risk
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
|
Romosozumab
n=218 participants at risk
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.3%
22/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.8%
28/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
9/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
11/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
5/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.5%
12/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.3%
22/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
2/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
13/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
22/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
12/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
19/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.3%
5/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
11/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
4/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
11/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
4.2%
9/214 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.4%
14/218 • 12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER