Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy (NCT NCT00919711)

NCT ID: NCT00919711

Last Updated: 2020-07-28

Results Overview

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

870 participants

Primary outcome timeframe

Baseline to month 12

Results posted on

2020-07-28

Participant Flow

Participants were enrolled from 19 October 2009 through 4 January 2011

Participant milestones

Participant milestones
Measure	Risedronate 150 mg QM Risedronate 150 mg oral once monthly	Denosumab 60 mg Q6M Denosumab 60 mg subcutaneous once every 6 months
Overall Study STARTED	435	435
Overall Study COMPLETED	402	422
Overall Study NOT COMPLETED	33	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Risedronate 150 mg QM Risedronate 150 mg oral once monthly	Denosumab 60 mg Q6M Denosumab 60 mg subcutaneous once every 6 months
Overall Study Withdrawal by Subject	15	7
Overall Study Adverse Event	13	3
Overall Study Other	1	2
Overall Study Administrative Decision	0	1
Overall Study Lost to Follow-up	2	0
Overall Study Death	1	0
Overall Study Noncompliance	1	0

Baseline Characteristics

Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risedronate 150 mg QM n=435 Participants Risedronate 150 mg oral once monthly	Denosumab 60 mg Q6M n=435 Participants Denosumab 60 mg subcutaneous once every 6 months	Total n=870 Participants Total of all reporting groups
Age, Continuous	67.7 Years STANDARD_DEVIATION 6.8 • n=5 Participants	67.8 Years STANDARD_DEVIATION 7.0 • n=7 Participants	67.7 Years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	435 Participants n=5 Participants	435 Participants n=7 Participants	870 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	425 Participants n=5 Participants	424 Participants n=7 Participants	849 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to month 12

Population: All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry

Outcome measures

Outcome measures
Measure	Risedronate 150 mg QM n=434 Participants Risedronate 150 mg oral once monthly	Denosumab 60 mg Q6M n=432 Participants Denosumab 60 mg subcutaneous once every 6 months
Total Hip BMD Percent Change From Baseline at Month 12	0.5 Percent Change From Baseline Interval 0.2 to 0.7	2.0 Percent Change From Baseline Interval 1.8 to 2.3

SECONDARY outcome

Timeframe: Baseline to month 1

Population: All randomized subjects who enrolled in the bone marker substudy with observed data

Serum Type-1 Collagen C-Telopeptide Percent Change From Baseline at Month 1

Outcome measures

Outcome measures
Measure	Risedronate 150 mg QM n=68 Participants Risedronate 150 mg oral once monthly	Denosumab 60 mg Q6M n=84 Participants Denosumab 60 mg subcutaneous once every 6 months
Serum CTX Percent Change From Baseline at Month 1	-17.0 Percent Change From Baseline Interval -36.8 to -1.6	-77.7 Percent Change From Baseline Interval -85.9 to -67.6

SECONDARY outcome

Timeframe: Baseline to month 12

Population: All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry

Outcome measures

Outcome measures
Measure	Risedronate 150 mg QM n=434 Participants Risedronate 150 mg oral once monthly	Denosumab 60 mg Q6M n=432 Participants Denosumab 60 mg subcutaneous once every 6 months
Femoral Neck BMD Percent Change From Baseline at Month 12	0.0 Percent Change From Baseline Interval -0.4 to 0.3	1.4 Percent Change From Baseline Interval 1.0 to 1.7

SECONDARY outcome

Timeframe: Baseline to month 12

Population: All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry

Outcome measures

Outcome measures
Measure	Risedronate 150 mg QM n=434 Participants Risedronate 150 mg oral once monthly	Denosumab 60 mg Q6M n=432 Participants Denosumab 60 mg subcutaneous once every 6 months
Lumbar Spine BMD Percent Change From Baseline at Month 12	1.1 Percent Change From Baseline Interval 0.7 to 1.5	3.4 Percent Change From Baseline Interval 3.1 to 3.8

Adverse Events

Risedronate 150 mg QM

Serious events: 35 serious events

Other events: 0 other events

Deaths: 0 deaths

Denosumab 60 mg Q6M

Serious events: 33 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

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 aftercompletion. 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

Serious adverse events
Measure	Risedronate 150 mg QM n=429 participants at risk	Denosumab 60 mg Q6M n=429 participants at risk
Cardiac disorders Atrial fibrillation	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.47% 2/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial flutter	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac arrest	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary artery disease	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary artery stenosis	0.47% 2/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocardial infarction	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Ventricular extrasystoles	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Congenital, familial and genetic disorders Talipes	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Macular hole	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain upper	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Coeliac disease	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Colonic pseudo-obstruction	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diverticular perforation	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastritis	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Pancreatitis	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Malaise	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Bile duct stone	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholelithiasis	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Jaundice	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Anaphylactic shock	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Appendicitis	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cellulitis	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Diverticulitis	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Herpes zoster	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Intervertebral discitis	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Lower respiratory tract infection	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia chlamydial	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Respiratory tract infection	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sinusitis	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urosepsis	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Femoral neck fracture	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Foot fracture	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Humerus fracture	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Joint injury	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Lip injury	0.23% 1/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/429 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.