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Effect of Full Length Parathyroid Hormone, PTH(1-84) or Strontium Ranelate on Bone Markers in Postmenopausal Women With Primary Osteoporosis (FP-006-IM)

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ClinicalTrials.gov Identifier: NCT00479037
Recruitment Status : Completed
First Posted : May 25, 2007
Results First Posted : June 28, 2011
Last Update Posted : May 8, 2012
Sponsor:
Information provided by:
Nycomed

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoporosis
Interventions Drug: Full Length Parathyroid Hormone, PTH(1-84)
Drug: Strontium Ranelate
Enrollment 82
Recruitment Details  
Pre-assignment Details 82 subjects were randomized. Of these, one subject was randomized, but consent was withdrawn during the screening period; the subject did not receive any treatment. Therefore, the Intention to treat set (ITT) consisted of 81 subjects.
Arm/Group Title PTH(1-84) Strontium Ranelate
Hide Arm/Group Description Once daily subcutaneous injection One sachet (2 g) per day, suspended in water
Period Title: Overall Study
Started 41 40
Completed 38 34
Not Completed 3 6
Arm/Group Title PTH(1-84) Strontium Ranelate Total
Hide Arm/Group Description Once daily subcutaneous injection One sachet (2 g) per day, suspended in water Total of all reporting groups
Overall Number of Baseline Participants 41 40 81
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 40 participants 81 participants
64.0  (8.64) 64.9  (8.49) 64.4  (8.52)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 41 participants 40 participants 81 participants
41 40 81
1.Primary Outcome
Title Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial
Hide Description

P1NP is a bone formation marker that is derived from the amino-terminal propeptides of type I collagen and is considered a quantitative measure of newly formed type I collagen.

Bone marker measurements were done by blood analysis.

Time Frame Baseline and 24 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.
Arm/Group Title PTH(1-84) Strontium Ranelate
Hide Arm/Group Description:
Once daily subcutaneous injection
One sachet (2 g) per day, suspended in water
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: percent change
446.1  (355.3) -6.2  (36.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PTH(1-84), Strontium Ranelate
Comments The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 360.3
Confidence Interval (2-Sided) 95%
256.5 to 494.3
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial
Hide Description

BSAP is a marker of bone formation that reflects the cellular activity of osteoblasts.

Bone marker measurements were done by blood analysis.

Time Frame Baseline and 24 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Number of participants analyzed = number of participants with data available.
Arm/Group Title PTH(1-84) Strontium Ranelate
Hide Arm/Group Description:
Once daily subcutaneous injection
One sachet (2 g) per day, suspended in water
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: percent change
129.6  (100.3) 4.9  (22.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PTH(1-84), Strontium Ranelate
Comments The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 92.9
Confidence Interval (2-Sided) 95%
63.8 to 127.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial
Hide Description

CTX is a marker of bone resorption, which is a degradation product of bone collagen.

Bone marker measurements were done by blood analysis.

Time Frame Baseline and 24 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Number of participants analyzed = number of participants with data available.
Arm/Group Title PTH(1-84) Strontium Ranelate
Hide Arm/Group Description:
Once daily subcutaneous injection
One sachet (2 g) per day, suspended in water
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: percent change
153.3  (132.4) -3.7  (36.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PTH(1-84), Strontium Ranelate
Comments The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value corresponding to the tests of treatment effect was adjusted using the Hochberg procedure.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 138.5
Confidence Interval (2-Sided) 95%
94.8 to 191.8
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description All safety analyses were based upon the safety set. The safety set consisted of all randomized subjects who had at least received one dose of trial drug
 
Arm/Group Title PTH(1-84) Strontium Ranelate
Hide Arm/Group Description Once daily subcutaneous injection One sachet (2 g) per day, suspended in water
All-Cause Mortality
PTH(1-84) Strontium Ranelate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PTH(1-84) Strontium Ranelate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/40 (5.00%)      2/40 (5.00%)    
Endocrine disorders     
Goitre  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Infections and infestations     
Urinary Tract Infection  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Nervous system disorders     
Syncope  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Vascular disorders     
Hypertensive Crisis  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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) Strontium Ranelate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/40 (72.50%)      19/40 (47.50%)    
Ear and labyrinth disorders     
Vertigo  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Gastrointestinal disorders     
Nausea, mild severity  1  5/40 (12.50%)  1/40 (2.50%) 
Nausea, moderate severity  1  3/40 (7.50%)  3/40 (7.50%) 
Abdominal pain upper  1  2/40 (5.00%)  2 1/40 (2.50%)  1
Diarrhoea  1  0/40 (0.00%)  0 2/40 (5.00%)  2
General disorders     
Malaise  1  3/40 (7.50%)  3 0/40 (0.00%)  0
Chills  1  0/40 (0.00%)  0 2/40 (5.00%)  2
Infections and infestations     
Tooth infection  1  1/40 (2.50%)  1 2/40 (5.00%)  2
Metabolism and nutrition disorders     
Hypercalcaemia / mild severity  1  8/40 (20.00%)  9 0/40 (0.00%)  0
Hypercalcaemia / moderate severity  1  3/40 (7.50%)  3 0/40 (0.00%)  0
Hypervitaminosis D  1  2/40 (5.00%)  2 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/40 (5.00%)  2 1/40 (2.50%)  1
Pain in extremity  1  2/40 (5.00%)  3 1/40 (2.50%)  1
Nervous system disorders     
Headache, mild severity  1  3/40 (7.50%)  3 2/40 (5.00%)  2
Headache, moderate severity  1  6/40 (15.00%)  7 1/40 (2.50%)  1
Psychiatric disorders     
Insomnia  1  0/40 (0.00%)  0 2/40 (5.00%)  2
Vascular disorders     
Hypertension  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Venous insufficiency  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
A limitation of the trial was the open label design, however this is not considered to affect the primary or secondary outcome of the trial.
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: Nycomed
ClinicalTrials.gov Identifier: NCT00479037     History of Changes
Other Study ID Numbers: FP-006-IM
2006-006065-16
First Submitted: May 23, 2007
First Posted: May 25, 2007
Results First Submitted: March 31, 2011
Results First Posted: June 28, 2011
Last Update Posted: May 8, 2012