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Trial record 20 of 101 for:    Risedronate

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

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ClinicalTrials.gov Identifier: NCT00919711
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : December 12, 2012
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoporosis
Interventions Drug: Actonel®
Drug: Denosumab
Enrollment 870
Recruitment Details Participants were enrolled from 19 October 2009 through 4 January 2011
Pre-assignment Details  
Arm/Group Title Risedronate 150 mg QM Denosumab 60 mg Q6M
Hide Arm/Group Description Risedronate 150 mg oral once monthly Denosumab 60 mg subcutaneous once every 6 months
Period Title: Overall Study
Started 435 435
Completed 402 422
Not Completed 33 13
Reason Not Completed
Withdrawal by Subject             15             7
Adverse Event             13             3
Other             1             2
Administrative Decision             0             1
Lost to Follow-up             2             0
Death             1             0
Noncompliance             1             0
Arm/Group Title Risedronate 150 mg QM Denosumab 60 mg Q6M Total
Hide Arm/Group Description Risedronate 150 mg oral once monthly Denosumab 60 mg subcutaneous once every 6 months Total of all reporting groups
Overall Number of Baseline Participants 435 435 870
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 435 participants 435 participants 870 participants
67.7  (6.8) 67.8  (7.0) 67.7  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 435 participants 435 participants 870 participants
Female
435
 100.0%
435
 100.0%
870
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 435 participants 435 participants 870 participants
White or Caucasian 425 424 849
Hispanic or Latino 6 7 13
Asian 4 3 7
Japanese 0 1 1
1.Primary Outcome
Title Total Hip BMD Percent Change From Baseline at Month 12
Hide Description Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry
Time Frame Baseline to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation
Arm/Group Title Risedronate 150 mg QM Denosumab 60 mg Q6M
Hide Arm/Group Description:
Risedronate 150 mg oral once monthly
Denosumab 60 mg subcutaneous once every 6 months
Overall Number of Participants Analyzed 434 432
Mean (95% Confidence Interval)
Unit of Measure: Percent Change From Baseline
0.5
(0.2 to 0.7)
2.0
(1.8 to 2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risedronate 150 mg QM, Denosumab 60 mg Q6M
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
1.2 to 2.0
Estimation Comments Denosumab - Risedronate
2.Secondary Outcome
Title Serum CTX Percent Change From Baseline at Month 1
Hide Description Serum Type-1 Collagen C-Telopeptide Percent Change From Baseline at Month 1
Time Frame Baseline to month 1
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who enrolled in the bone marker substudy with observed data
Arm/Group Title Risedronate 150 mg QM Denosumab 60 mg Q6M
Hide Arm/Group Description:
Risedronate 150 mg oral once monthly
Denosumab 60 mg subcutaneous once every 6 months
Overall Number of Participants Analyzed 68 84
Median (Inter-Quartile Range)
Unit of Measure: Percent Change From Baseline
-17.0
(-36.8 to -1.6)
-77.7
(-85.9 to -67.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risedronate 150 mg QM, Denosumab 60 mg Q6M
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Femoral Neck BMD Percent Change From Baseline at Month 12
Hide Description Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry
Time Frame Baseline to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation
Arm/Group Title Risedronate 150 mg QM Denosumab 60 mg Q6M
Hide Arm/Group Description:
Risedronate 150 mg oral once monthly
Denosumab 60 mg subcutaneous once every 6 months
Overall Number of Participants Analyzed 434 432
Mean (95% Confidence Interval)
Unit of Measure: Percent Change From Baseline
0.0
(-0.4 to 0.3)
1.4
(1.0 to 1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risedronate 150 mg QM, Denosumab 60 mg Q6M
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
0.9 to 1.8
Estimation Comments Denosumab - Risedronate
4.Secondary Outcome
Title Lumbar Spine BMD Percent Change From Baseline at Month 12
Hide Description Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry
Time Frame Baseline to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation
Arm/Group Title Risedronate 150 mg QM Denosumab 60 mg Q6M
Hide Arm/Group Description:
Risedronate 150 mg oral once monthly
Denosumab 60 mg subcutaneous once every 6 months
Overall Number of Participants Analyzed 434 432
Mean (95% Confidence Interval)
Unit of Measure: Percent Change From Baseline
1.1
(0.7 to 1.5)
3.4
(3.1 to 3.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risedronate 150 mg QM, Denosumab 60 mg Q6M
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
1.8 to 2.8
Estimation Comments Denosumab - Risedronate
Time Frame 12 months
Adverse Event Reporting Description The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
 
Arm/Group Title Risedronate 150 mg QM Denosumab 60 mg Q6M
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Risedronate 150 mg QM Denosumab 60 mg Q6M
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Risedronate 150 mg QM Denosumab 60 mg Q6M
Affected / at Risk (%) Affected / at Risk (%)
Total   35/429 (8.16%)   33/429 (7.69%) 
Cardiac disorders     
Atrial fibrillation  1  0/429 (0.00%)  2/429 (0.47%) 
Atrial flutter  1  1/429 (0.23%)  0/429 (0.00%) 
Cardiac arrest  1  1/429 (0.23%)  0/429 (0.00%) 
Coronary artery disease  1  1/429 (0.23%)  0/429 (0.00%) 
Coronary artery stenosis  1  2/429 (0.47%)  0/429 (0.00%) 
Myocardial infarction  1  1/429 (0.23%)  0/429 (0.00%) 
Ventricular extrasystoles  1  0/429 (0.00%)  1/429 (0.23%) 
Congenital, familial and genetic disorders     
Talipes  1  0/429 (0.00%)  1/429 (0.23%) 
Eye disorders     
Macular hole  1  1/429 (0.23%)  0/429 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper  1  1/429 (0.23%)  0/429 (0.00%) 
Coeliac disease  1  0/429 (0.00%)  1/429 (0.23%) 
Colonic pseudo-obstruction  1  0/429 (0.00%)  1/429 (0.23%) 
Constipation  1  1/429 (0.23%)  0/429 (0.00%) 
Diarrhoea  1  1/429 (0.23%)  0/429 (0.00%) 
Diverticular perforation  1  1/429 (0.23%)  0/429 (0.00%) 
Gastritis  1  1/429 (0.23%)  0/429 (0.00%) 
Pancreatitis  1  1/429 (0.23%)  1/429 (0.23%) 
General disorders     
Malaise  1  0/429 (0.00%)  1/429 (0.23%) 
Hepatobiliary disorders     
Bile duct stone  1  1/429 (0.23%)  0/429 (0.00%) 
Cholelithiasis  1  1/429 (0.23%)  1/429 (0.23%) 
Jaundice  1  0/429 (0.00%)  1/429 (0.23%) 
Immune system disorders     
Anaphylactic shock  1  1/429 (0.23%)  0/429 (0.00%) 
Infections and infestations     
Appendicitis  1  1/429 (0.23%)  0/429 (0.00%) 
Cellulitis  1  1/429 (0.23%)  0/429 (0.00%) 
Diverticulitis  1  0/429 (0.00%)  1/429 (0.23%) 
Herpes zoster  1  1/429 (0.23%)  0/429 (0.00%) 
Intervertebral discitis  1  0/429 (0.00%)  1/429 (0.23%) 
Lower respiratory tract infection  1  1/429 (0.23%)  0/429 (0.00%) 
Pneumonia  1  1/429 (0.23%)  0/429 (0.00%) 
Pneumonia chlamydial  1  1/429 (0.23%)  0/429 (0.00%) 
Respiratory tract infection  1  0/429 (0.00%)  1/429 (0.23%) 
Sinusitis  1  0/429 (0.00%)  1/429 (0.23%) 
Urosepsis  1  0/429 (0.00%)  1/429 (0.23%) 
Injury, poisoning and procedural complications     
Femoral neck fracture  1  1/429 (0.23%)  1/429 (0.23%) 
Femur fracture  1  0/429 (0.00%)  1/429 (0.23%) 
Fibula fracture  1  0/429 (0.00%)  1/429 (0.23%) 
Foot fracture  1  1/429 (0.23%)  0/429 (0.00%) 
Humerus fracture  1  1/429 (0.23%)  0/429 (0.00%) 
Joint injury  1  1/429 (0.23%)  0/429 (0.00%) 
Lip injury  1  1/429 (0.23%)  0/429 (0.00%) 
Lumbar vertebral fracture  1  0/429 (0.00%)  1/429 (0.23%) 
Procedural pain  1  0/429 (0.00%)  1/429 (0.23%) 
Pubis fracture  1  0/429 (0.00%)  1/429 (0.23%) 
Radius fracture  1  0/429 (0.00%)  2/429 (0.47%) 
Ulna fracture  1  0/429 (0.00%)  1/429 (0.23%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  1/429 (0.23%)  0/429 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/429 (0.00%)  2/429 (0.47%) 
Intervertebral disc protrusion  1  0/429 (0.00%)  1/429 (0.23%) 
Meniscal degeneration  1  0/429 (0.00%)  1/429 (0.23%) 
Osteoarthritis  1  1/429 (0.23%)  2/429 (0.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anal cancer  1  0/429 (0.00%)  1/429 (0.23%) 
Bladder cancer  1  0/429 (0.00%)  1/429 (0.23%) 
Breast cancer  1  2/429 (0.47%)  1/429 (0.23%) 
Endometrial cancer  1  1/429 (0.23%)  0/429 (0.00%) 
Metastases to neck  1  1/429 (0.23%)  0/429 (0.00%) 
Metastatic neoplasm  1  1/429 (0.23%)  0/429 (0.00%) 
Transitional cell carcinoma  1  1/429 (0.23%)  0/429 (0.00%) 
Nervous system disorders     
Carotid artery occlusion  1  0/429 (0.00%)  1/429 (0.23%) 
Carotid artery stenosis  1  1/429 (0.23%)  0/429 (0.00%) 
Carpal tunnel syndrome  1  1/429 (0.23%)  0/429 (0.00%) 
Cerebral ischaemia  1  0/429 (0.00%)  2/429 (0.47%) 
Cerebrovascular accident  1  0/429 (0.00%)  2/429 (0.47%) 
Presyncope  1  1/429 (0.23%)  0/429 (0.00%) 
Radicular syndrome  1  0/429 (0.00%)  1/429 (0.23%) 
Syncope  1  0/429 (0.00%)  1/429 (0.23%) 
Renal and urinary disorders     
Haematuria  1  1/429 (0.23%)  0/429 (0.00%) 
Nephrolithiasis  1  0/429 (0.00%)  1/429 (0.23%) 
Reproductive system and breast disorders     
Vaginal prolapse  1  0/429 (0.00%)  1/429 (0.23%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/429 (0.23%)  0/429 (0.00%) 
Bronchopneumopathy  1  1/429 (0.23%)  0/429 (0.00%) 
Chronic obstructive pulmonary disease  1  1/429 (0.23%)  0/429 (0.00%) 
Lung infiltration  1  1/429 (0.23%)  0/429 (0.00%) 
Pneumothorax  1  1/429 (0.23%)  0/429 (0.00%) 
Vascular disorders     
Phlebitis  1  1/429 (0.23%)  0/429 (0.00%) 
Temporal arteritis  1  0/429 (0.00%)  1/429 (0.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Risedronate 150 mg QM Denosumab 60 mg Q6M
Affected / at Risk (%) Affected / at Risk (%)
Total   0/429 (0.00%)   0/429 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00919711     History of Changes
Other Study ID Numbers: 20080099
First Submitted: June 11, 2009
First Posted: June 12, 2009
Results First Submitted: November 15, 2012
Results First Posted: December 12, 2012
Last Update Posted: September 12, 2018