BRIDGE: A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02186171
• Collaborator: (none)
• Enrollment: 245
• Locations: 34
• Arms: 2
• Actual Duration (Months): 22.1
• Patients Per Site: 7.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine. Additionally, the study will assess the effect of treatment with romosozumab for 12 months compared with placebo on BMD at the femoral neck and total hip.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis in Men	Biological: Romosozumab; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 245 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
• Actual Study Start Date: Jun 16, 2014
• Actual Primary Completion Date: Feb 15, 2016
• Actual Study Completion Date: Apr 20, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Romosozumab Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.	Biological: Romosozumab; Administered by subcutaneous injection once a month.; Other Names: AMG 785 EVENITY™
Placebo Comparator: Placebo Participants received placebo subcutaneous injections once a month for 12 months.	Drug: Placebo; Administered by subcutaneous injection once a month.

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12 [Baseline and month 12]

   Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Secondary Outcome Measures

1. Percent Change From Baseline in BMD at the Total Hip at Month 12 [Baseline and month 12]

   Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

2. Percent Change From Baseline in BMD at the Femoral Neck at Month 12 [Baseline and month 12]

   Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

3. Percent Change From Baseline in Lumbar Spine BMD at Month 6 [Baseline and month 6]

   Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

4. Percent Change From Baseline in BMD at the Total Hip at Month 6 [Baseline and month 6]

   Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

5. Percent Change From Baseline in BMD at the Femoral Neck at Month 6 [Baseline and month 6]

   Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 90 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age

• Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral fracture.

Exclusion Criteria:

• A BMD T score ≤ -3.50 at the hip,

• History of hip fracture

• Severe metabolic bone diseases

• Significant laboratory abnormalities

• Recent treatment with agents affecting bone metabolism

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Lakewood	Colorado	United States	80227
2	Research Site	Bethesda	Maryland	United States	20817
3	Research Site	Albuquerque	New Mexico	United States	87106
4	Research Site	Genk		Belgium	3600
5	Research Site	Gent		Belgium	9000
6	Research Site	Leuven		Belgium	3000
7	Research Site	Liège		Belgium	4020
8	Research Site	Medellin	Antioquia	Colombia	050021
9	Research Site	Bogota	Cundinamarca	Colombia	11001000
10	Research Site	Ostrava-Trebovice		Czechia	722 00
11	Research Site	Plzen		Czechia	305 99
12	Research Site	Praha 11 - Chodov		Czechia	148 00
13	Research Site	Aalborg		Denmark	9000
14	Research Site	Ballerup		Denmark	2750
15	Research Site	Mizunami-shi	Gifu	Japan	509-6134
16	Research Site	Yokohama-shi	Kanagawa	Japan	223-0062
17	Research Site	Bungoono-shi	Oita	Japan	879-7125
18	Research Site	Takatsuki-shi	Osaka	Japan	569-1123
19	Research Site	Hachioji-shi	Tokyo	Japan	192-0046
20	Research Site	Shinagawa-ku	Tokyo	Japan	140-0011
21	Research Site	Toshima-ku	Tokyo	Japan	171-0033
22	Research Site	Mexicali	Baja California Norte	Mexico	21100
23	Research Site	Monterrey	Nuevo León	Mexico	64460
24	Research Site	Culiacan	Sinaloa	Mexico	80000
25	Research Site	Lodz		Poland	90-558
26	Research Site	Swidnik		Poland	21-040
27	Research Site	Warszawa		Poland	01-192
28	Research Site	Wroclaw		Poland	50-088
29	Research Site	Moscow		Russian Federation	101990
30	Research Site	Saint-Petersburg		Russian Federation	190103
31	Research Site	Yaroslavl		Russian Federation	150003
32	Research Site	Bern		Switzerland	3010
33	Research Site	Zurich		Switzerland	8063
34	Research Site	Zurich		Switzerland	8091

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website

Publications

• Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, Miyauchi A, Maddox J, Chen L, Horlait S. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3183-3193. doi: 10.1210/jc.2017-02163.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT02186171
• Other Study ID Numbers: 20110174; 2013-005551-32
• First Posted: Jul 10, 2014
• Last Update Posted: May 28, 2019
• Last Verified: May 1, 2019

• Keywords provided by Amgen: Osteoporosis in men
• Additional relevant MeSH terms: Osteoporosis

Study Results

Participant Flow

Recruitment Details	This study was conducted at 31 centers in Europe, North America, Latin America, and Japan. Participants were enrolled from 16 June 2014 to 27 January 2015.
Pre-assignment Detail	Participants were randomized in a 2:1 ratio to receive 210 mg romosozumab or matched placebo in a blinded fashion for the duration of the 12-month treatment period. Randomization was stratified by geographic region (Europe, North America, Latin America, and Japan).

Arm/Group Title	Placebo	Romosozumab 210 mg
Arm/Group Description	Participants received placebo subcutaneous injections once a month (QM) for 12 months.	Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Period Title: Overall Study
STARTED	82	163
Received Treatment	81	163
COMPLETED	78	148
NOT COMPLETED	4	15

Baseline Characteristics

Arm/Group Title	Placebo	Romosozumab 210 mg	Total
Arm/Group Description	Participants received placebo subcutaneous injections once a month (QM) for 12 months.	Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.	Total of all reporting groups
Overall Participants	82	163	245
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.5 (6.9)	72.4 (7.4)	72.1 (7.3)
Age, Customized (Count of Participants)
18 - 64 years	11 13.4%	31 19%	42 17.1%
65 - 74 years	42 51.2%	62 38%	104 42.4%
75 years and over	29 35.4%	70 42.9%	99 40.4%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	82 100%	163 100%	245 100%
Race (Count of Participants)
White	60 73.2%	120 73.6%	180 73.5%
Asian	9 11%	18 11%	27 11%
Black or African American	0 0%	1 0.6%	1 0.4%
Other	13 15.9%	23 14.1%	36 14.7%
Multiple	0 0%	1 0.6%	1 0.4%
Geographic Region (Count of Participants)
Europe	54 65.9%	108 66.3%	162 66.1%
Japan	9 11%	18 11%	27 11%
Latin America	12 14.6%	23 14.1%	35 14.3%
North America	7 8.5%	14 8.6%	21 8.6%
Lumbar Spine Bone Mineral Density T-score (T-score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [T-score]	-2.33 (1.41)	-2.22 (1.19)	-2.26 (1.27)
Total Hip BMD T-score (T-score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [T-score]	-1.92 (0.65)	-1.92 (0.59)	-1.92 (0.61)
Femoral Neck BMD T-score (T-score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [T-score]	-2.30 (0.52)	-2.34 (0.52)	-2.33 (0.52)

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12
Description	Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time Frame	Baseline and month 12

Outcome Measure Data

Analysis Population Description

Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the lumbar spine; last observation carried forward (LOCF) imputation was used.

Arm/Group Title	Placebo	Romosozumab 210 mg
Arm/Group Description	Participants received placebo subcutaneous injections once a month (QM) for 12 months.	Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Measure Participants	79	157
Least Squares Mean (Standard Error) [percent change]	1.2 (0.5)	12.1 (0.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Romosozumab 210 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments	ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	10.9
	Confidence Interval	(2-Sided) 95%; 9.6 to 12.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments

2. Secondary Outcome

Title	Percent Change From Baseline in BMD at the Total Hip at Month 12
Description	Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time Frame	Baseline and month 12

Outcome Measure Data

Analysis Population Description

Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the total hip; LOCF imputation was used.

Arm/Group Title	Placebo	Romosozumab 210 mg
Arm/Group Description	Participants received placebo subcutaneous injections once a month (QM) for 12 months.	Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Measure Participants	79	158
Least Squares Mean (Standard Error) [percent change]	-0.5 (0.3)	2.5 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Romosozumab 210 mg
	Comments
	Type of Statistical Test	Superiority
	Comments	The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments	ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	3.0
	Confidence Interval	(2-Sided) 95%; 2.3 to 3.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments

3. Secondary Outcome

Title	Percent Change From Baseline in BMD at the Femoral Neck at Month 12
Description	Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time Frame	Baseline and month 12

Outcome Measure Data

Analysis Population Description

Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the femoral neck; LOCF imputation was used.

Arm/Group Title	Placebo	Romosozumab 210 mg
Arm/Group Description	Participants received placebo subcutaneous injections once a month (QM) for 12 months.	Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Measure Participants	79	158
Least Squares Mean (Standard Error) [percent change]	-0.2 (0.4)	2.2 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Romosozumab 210 mg
	Comments
	Type of Statistical Test	Superiority
	Comments	The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments	ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95%; 1.5 to 3.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.5
	Estimation Comments

4. Secondary Outcome

Title	Percent Change From Baseline in Lumbar Spine BMD at Month 6
Description	Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time Frame	Baseline and month 6

Outcome Measure Data

Analysis Population Description

Primary efficacy analysis subset with available data at baseline and month 6.

Arm/Group Title	Placebo	Romosozumab 210 mg
Arm/Group Description	Participants received placebo subcutaneous injections once a month (QM) for 12 months.	Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Measure Participants	78	156
Least Squares Mean (Standard Error) [percent change]	0.3 (0.4)	9.0 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Romosozumab 210 mg
	Comments
	Type of Statistical Test	Superiority
	Comments	The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments	ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	8.7
	Confidence Interval	(2-Sided) 95%; 7.6 to 9.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.5
	Estimation Comments

5. Secondary Outcome

Title	Percent Change From Baseline in BMD at the Total Hip at Month 6
Description	Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time Frame	Baseline and month 6

Outcome Measure Data

Analysis Population Description

Primary efficacy analysis subset with available data at baseline and month 6.

Arm/Group Title	Placebo	Romosozumab 210 mg
Arm/Group Description	Participants received placebo subcutaneous injections once a month (QM) for 12 months.	Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Measure Participants	78	157
Least Squares Mean (Standard Error) [percent change]	0.2 (0.2)	1.6 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Romosozumab 210 mg
	Comments
	Type of Statistical Test	Superiority
	Comments	The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments	ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; 0.8 to 2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3
	Estimation Comments

6. Secondary Outcome

Title	Percent Change From Baseline in BMD at the Femoral Neck at Month 6
Description	Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time Frame	Baseline and month 6

Outcome Measure Data

Analysis Population Description

Primary efficacy analysis subset with available data at baseline and month 6.

Arm/Group Title	Placebo	Romosozumab 210 mg
Arm/Group Description	Participants received placebo subcutaneous injections once a month (QM) for 12 months.	Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Measure Participants	78	157
Least Squares Mean (Standard Error) [percent change]	0.0 (0.4)	1.2 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Romosozumab 210 mg
	Comments
	Type of Statistical Test	Superiority
	Comments	The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.
Statistical Test of Hypothesis	p-Value	= 0.0033
	Comments	ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 0.4 to 2.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments

Adverse Events

Time Frame	15 months
Adverse Event Reporting Description	Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Arm/Group Title	Placebo		Romosozumab 210 mg
Arm/Group Description	Participants received placebo subcutaneous injections once a month (QM) for 12 months.		Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
All Cause Mortality
	Placebo		Romosozumab 210 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Romosozumab 210 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/81 (12.3%)		23/163 (14.1%)
Cardiac disorders
Angina unstable	0/81 (0%)		1/163 (0.6%)
Atrial fibrillation	1/81 (1.2%)		0/163 (0%)
Atrial flutter	1/81 (1.2%)		1/163 (0.6%)
Cardiac failure	0/81 (0%)		1/163 (0.6%)
Cardiac valve disease	1/81 (1.2%)		0/163 (0%)
Cardio-respiratory arrest	0/81 (0%)		1/163 (0.6%)
Coronary artery stenosis	0/81 (0%)		1/163 (0.6%)
Myocardial ischaemia	0/81 (0%)		2/163 (1.2%)
Wolff-Parkinson-White syndrome	0/81 (0%)		1/163 (0.6%)
Gastrointestinal disorders
Abdominal pain	1/81 (1.2%)		0/163 (0%)
Abdominal pain upper	1/81 (1.2%)		0/163 (0%)
Gastrooesophageal reflux disease	0/81 (0%)		1/163 (0.6%)
Intra-abdominal haemorrhage	1/81 (1.2%)		0/163 (0%)
General disorders
Death	1/81 (1.2%)		1/163 (0.6%)
Implant site haematoma	0/81 (0%)		1/163 (0.6%)
Non-cardiac chest pain	1/81 (1.2%)		1/163 (0.6%)
Hepatobiliary disorders
Cholecystitis	0/81 (0%)		1/163 (0.6%)
Infections and infestations
Appendicitis	0/81 (0%)		1/163 (0.6%)
Appendicitis perforated	0/81 (0%)		1/163 (0.6%)
Atypical pneumonia	1/81 (1.2%)		0/163 (0%)
Device related infection	0/81 (0%)		1/163 (0.6%)
Escherichia sepsis	0/81 (0%)		1/163 (0.6%)
Pneumonia	0/81 (0%)		2/163 (1.2%)
Pneumonia bacterial	1/81 (1.2%)		0/163 (0%)
Urinary tract infection	0/81 (0%)		1/163 (0.6%)
Injury, poisoning and procedural complications
Anaemia postoperative	0/81 (0%)		1/163 (0.6%)
Femur fracture	1/81 (1.2%)		0/163 (0%)
Humerus fracture	1/81 (1.2%)		0/163 (0%)
Laceration	0/81 (0%)		1/163 (0.6%)
Rib fracture	0/81 (0%)		1/163 (0.6%)
Subdural haematoma	0/81 (0%)		1/163 (0.6%)
Thoracic vertebral fracture	0/81 (0%)		1/163 (0.6%)
Upper limb fracture	1/81 (1.2%)		0/163 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	0/81 (0%)		1/163 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/81 (0%)		1/163 (0.6%)
Oropharyngeal cancer	0/81 (0%)		1/163 (0.6%)
Nervous system disorders
Carotid arteriosclerosis	0/81 (0%)		1/163 (0.6%)
Carotid artery stenosis	0/81 (0%)		1/163 (0.6%)
Cerebral ischaemia	0/81 (0%)		1/163 (0.6%)
Cerebrovascular accident	0/81 (0%)		1/163 (0.6%)
Dementia Alzheimer's type	1/81 (1.2%)		0/163 (0%)
Epilepsy	1/81 (1.2%)		0/163 (0%)
Haemorrhagic stroke	0/81 (0%)		1/163 (0.6%)
Lacunar infarction	1/81 (1.2%)		0/163 (0%)
Syncope	1/81 (1.2%)		0/163 (0%)
Vascular encephalopathy	0/81 (0%)		1/163 (0.6%)
Psychiatric disorders
Depressed mood	0/81 (0%)		1/163 (0.6%)
Depression	0/81 (0%)		1/163 (0.6%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/81 (0%)		1/163 (0.6%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/81 (1.2%)		0/163 (0%)
Emphysema	1/81 (1.2%)		0/163 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Romosozumab 210 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/81 (50.6%)		74/163 (45.4%)
Gastrointestinal disorders
Constipation	1/81 (1.2%)		9/163 (5.5%)
Infections and infestations
Nasopharyngitis	22/81 (27.2%)		35/163 (21.5%)
Injury, poisoning and procedural complications
Procedural pain	6/81 (7.4%)		8/163 (4.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	8/81 (9.9%)		10/163 (6.1%)
Back pain	4/81 (4.9%)		15/163 (9.2%)
Muscle spasms	5/81 (6.2%)		3/163 (1.8%)
Myalgia	5/81 (6.2%)		4/163 (2.5%)
Nervous system disorders
Headache	6/81 (7.4%)		10/163 (6.1%)
Vascular disorders
Hypertension	5/81 (6.2%)		14/163 (8.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.