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Trial record 72 of 101 for:    Risedronate

Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM) (PEAK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00365456
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : July 20, 2012
Last Update Posted : August 20, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoporosis
Interventions Drug: Parathyroid Hormone (PTH)
Drug: Risedronate
Enrollment 407
Recruitment Details

The trial was divided into 3 consecutive open-label treatment phases of 12 months with randomisation after Trial Period II.

From 407 enrolled patients in total, 2 patients were enrolled but were never exposed to trial treatment. Thus, 405 patients in total received trial treatment.

Pre-assignment Details
  • Period I: total number of 405 patients were included and all received PTH(1-84) treatment for 1 year
  • Period II: of those 405 patients, 282 continued into the 2. year and all received risedronate
  • Period III: during the 3. year, the remaining 268 patients were randomised to either PTH(1-84) (=136 patients) or risedronate (=132 patients)
Arm/Group Title PTH (1-84) Risedronate
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Trial Period I (12 Months)
Started 407 0
Completed 282 0
Not Completed 125 0
Reason Not Completed
Adverse Event             84             0
Non-compliance             3             0
Withdrawal by Subject             27             0
Other             11             0
Period Title: Trial Period II (12 Months)
Started 0 282
Completed 0 268
Not Completed 0 14
Reason Not Completed
Adverse Event             0             6
Non-compliance             0             2
Withdrawal by Subject             0             5
Other             0             1
Period Title: Trial Period III (12 Months)
Started 136 132
Completed 118 127
Not Completed 18 5
Reason Not Completed
Adverse Event             13             3
Withdrawal by Subject             4             1
Other             1             1
Arm/Group Title PTH(1-84) or Risedronate
Hide Arm/Group Description
  • PTH(1-84) received by 405 participants in Trial Period I
  • of those 405 participants, 282 received Risedronate in Trial Period II
  • of those 282 participants, 268 participant remained and 136 received PTH(1-84) and 132 received Risedronate in Trial Period III
Overall Number of Baseline Participants 405
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 405 participants
Trial Period I / PTH(1-84) 64.6  (7.46)
Trial Period II / Risedronate 64.2  (7.43)
Trial Period III / PTH(1-84) 63.4  (6.94)
Trial Period III / Risedronate 64.7  (7.91)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
female Number Analyzed 405 participants
405
Lumbar spine T-score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 405 participants
Trial Period I / PTH(1-84) -3.61  (0.490)
Trial Period II / Risedronate -3.62  (0.472)
Trial Period III / PTH(1-84) -3.60  (0.427)
Trial Period III / Risedronate -3.63  (0.518)
[1]
Measure Description: The T-score represents the lumbar spine bone mineral density as compared to a young normal reference mean (healthy 30-year-old woman). A score ≥ -1.0 is considered Normal, while a score between -1.0 and -2.5 is defined as Osteopenia and a score ≤ -2.5 is defined as Osteoporosis.
Prevalent vertebral fractures   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 405 participants
Trial Period I / PTH(1-84) 105
Trial Period II / Risedronate 71
Trial Period III / PTH(1-84) 37
Trial Period III / Risedronate 29
[1]
Measure Description: Number of patients with at least one vertebral fracture at baseline
Prevalent non-vertebral fragility fractures  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 405 participants
Trial Period I / PTH(1-84): hip fractures 9
Trial Period II / Risedronate: hip fractures 5
Trial Period III / PTH(1-84): hip fractures 1
Trial Period III / Risedronate: hip fractures 3
Trial Period I / PTH(1-84): wrist fractures 78
Trial Period II / Risedronate: wrist fractures 50
Trial Period III / PTH(1-84): wrist fractures 22
Trial Period III / Risedronate: wrist fractures 25
Trial Period I / PTH(1-84): others 93
Trial Period II / Risedronate: others 59
Trial Period III / PTH(1-84): others 28
Trial Period III / Risedronate: others 27
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 405 participants
Trial Period I / PTH(1-84) 59.5  (9.39)
Trial Period II / Risedronate 59.7  (9.17)
Trial Period III / PTH(1-84) 59.6  (8.66)
Trial Period III / Risedronate 59.8  (9.57)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 405 participants
Trial Period I / PTH(1-84) 157.4  (6.40)
Trial Period II / Risedronate 157.5  (6.48)
Trial Period III / PTH(1-84) 157.6  (6.21)
Trial Period III / Risedronate 157.4  (6.86)
Serum Calcium  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 405 participants
Trial Period I / PTH(1-84) 2.338  (0.1022)
Trial Period II / Risedronate 2.337  (0.0999)
Trial Period III / PTH(1-84) 2.337  (0.0961)
Trial Period III / Risedronate 2.339  (0.1041)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 405 participants
Trial Period I / PTH(1-84) 24.06  (3.861)
Trial Period II / Risedronate 24.11  (3.788)
Trial Period III / PTH(1-84) 24.06  (3.618)
Trial Period III / Risedronate 24.21  (3.933)
1.Primary Outcome
Title Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.
Hide Description BMD was measured by Dual X-ray Absorptiometry (DXA).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients made the Full Analysis Set which was used for the primary and secondary analyses according to intention-to-treat principles. One participant excluded due to missing baseline data at trial period III entry, thus no data could be carried forward for this patient. Missing values imputed by Last Observation Carried Forward.
Arm/Group Title PTH (1-84) Risedronate
Hide Arm/Group Description:
Regimen 1 = PTH (1-84) → Risedronate → PTH (1-84)
Regimen 2 = PTH (1-84) → Risedronate → Risedronate
Overall Number of Participants Analyzed 135 132
Least Squares Mean (Standard Error)
Unit of Measure: Percentage Change
1.002  (1.0037) 0.990  (1.0034)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PTH (1-84), Risedronate
Comments An analysis of covariance (ANCOVA) model was used including treatment group, stratum and pooled centre as fixed effects and log (BMD at Baseline III (month 24)) as a covariate (log-normally distributed data assumed). Least square mean change from baseline III (month 24), 95% confidence interval and p-value for the treatment effect (PTH (1-84) vs. Risedronate) was calculated. Superiority was claimed if lower limit of the interval was above 1. Results were back-transformed from the log scale.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments No multiplicity correction of the significance level was performed as only one primary endpoint was planned.
Method ANCOVA
Comments Estimation allowing for unequal variance in the two treatment groups and robust estimates for the standard errors were obtained.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.012
Confidence Interval (2-Sided) 95%
1.003 to 1.021
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.0045
Estimation Comments [Not Specified]
Time Frame Over three years of the trial duration.
Adverse Event Reporting Description

The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP.

At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.

 
Arm/Group Title PTH (1-84) Risedronate
Hide Arm/Group Description Trial Period I SAEs and Trial Period III SAEs for subjects receiving PTH (1-84) Trial Period II SAEs and Trial Period III SAEs for subjects receiving risedronate
All-Cause Mortality
PTH (1-84) Risedronate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PTH (1-84) Risedronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/405 (8.15%)      32/282 (11.35%)    
Cardiac disorders     
Acute myocardial infarction  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Arrhythmia  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Atrial fibrillation  1  0/405 (0.00%)  0 2/282 (0.71%)  2
Coronary artery disease  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Myocardial infarction  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Ear and labyrinth disorders     
Vertigo  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Endocrine disorders     
Goitre  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Eye disorders     
Cataract  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Eye disorder  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Retinal detachment  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Retinal vein thrombosis  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Gastrointestinal disorders     
Constipation  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Abdominal adhesions  1  0/405 (0.00%)  0 1/282 (0.35%)  1
General disorders     
Condition aggravated  1  1/405 (0.25%)  1 2/282 (0.71%)  2
Hepatobiliary disorders     
Cholelithiasis  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Infections and infestations     
Diverticulitis  1  2/405 (0.49%)  2 0/282 (0.00%)  0
Pneumonia  1  1/405 (0.25%)  1 1/282 (0.35%)  1
Gastroenteritis  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Contusion  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Multiple injuries  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Patella fracture  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Pelvic fracture  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Thoracic vertebral fracture  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Ulna fracture  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Upper limb fracture  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Foot fracture  1  0/405 (0.00%)  0 2/282 (0.71%)  2
Impacted fracture  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Lower limb fracture  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Wrist fracture  1  0/405 (0.00%)  0 2/282 (0.71%)  2
Investigations     
Electrocardiogram QT prolonged  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Metabolism and nutrition disorders     
Lactose intolerance  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Musculoskeletal and connective tissue disorders     
Metatarsalgia  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Myalgia  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Arthralgia  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Foot deformity  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Groin pain  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Intervertebral disc protrusion  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Musculoskeletal chest pain  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Osteoarthritis  1  0/405 (0.00%)  0 2/282 (0.71%)  2
Pain in extremity  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Colon cancer  1  1/405 (0.25%)  1 1/282 (0.35%)  1
Essential thrombocythaemia  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Gastric neoplasm  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Thyroid neoplasm  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Benign neoplasm of thyroid gland  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Mesothelioma  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Nervous system disorders     
Dizziness  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Paraesthesia  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Syncope  1  1/405 (0.25%)  1 1/282 (0.35%)  1
Renal and urinary disorders     
Urinary incontinence  1  2/405 (0.49%)  2 2/282 (0.71%)  2
Nephrotic syndrome  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Reproductive system and breast disorders     
Uterine polyp  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/405 (0.25%)  1 1/282 (0.35%)  1
Lung disorder  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Respiratory disorder  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin lesion  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Surgical and medical procedures     
Bunion operation  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Medical device removal  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Vascular disorders     
Angiopathy  1  1/405 (0.25%)  1 0/282 (0.00%)  0
Femoral arterial stenosis  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Hypertensive crisis  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Intermittent claudication  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Orthostatic hypotension  1  0/405 (0.00%)  0 1/282 (0.35%)  1
Peripheral arterial occlusive disease  1  0/405 (0.00%)  0 1/282 (0.35%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PTH (1-84) Risedronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   365/405 (90.12%)      95/282 (33.69%)    
Ear and labyrinth disorders     
Vertigo  1  24/405 (5.93%)  26 0/282 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  98/405 (24.20%)  123 0/282 (0.00%)  0
General disorders     
Asthenia  1  23/405 (5.68%)  24 0/282 (0.00%)  0
Infections and infestations     
Urinary tract infection  1  23/405 (5.68%)  28 14/282 (4.96%)  16
Influenza  1  0/405 (0.00%)  0 20/282 (7.09%)  24
Metabolism and nutrition disorders     
Hypercalcaemia  1  87/405 (21.48%)  105 17/282 (6.03%)  20
Musculoskeletal and connective tissue disorders     
Back pain  1  31/405 (7.65%)  32 15/282 (5.32%)  15
Arthralgia  1  0/405 (0.00%)  0 14/282 (4.96%)  16
Osteoarthritis  1  0/405 (0.00%)  0 15/282 (5.32%)  16
Nervous system disorders     
Headache  1  35/405 (8.64%)  40 0/282 (0.00%)  0
Renal and urinary disorders     
Hypercalciuria  1  121/405 (29.88%)  150 0/282 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
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.
After publication of the results or 24 months after Clinical Trial Report has been finalised, whichever comes first, Nycomed acknowledge the Investigator's rights to publish results from this trial. Any such scientific paper, presentation, communication, or other information concerning the investigation described in this protocol, must be submitted to Nycomed prior to submission for publication/presentation for review. Review comments will be given within a month from receipt of the manuscript.
Results Point of Contact
Name/Title: Clinical Trial Operations
Organization: Nycomed
Phone: +45 4677 1111
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00365456     History of Changes
Other Study ID Numbers: FP-001-IM
2005-000730-20 ( EudraCT Number )
U1111-1132-3246 ( Registry Identifier: WHO )
First Submitted: August 9, 2006
First Posted: August 17, 2006
Results First Submitted: May 4, 2012
Results First Posted: July 20, 2012
Last Update Posted: August 20, 2012