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Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT01321723
Recruitment Status : Completed
First Posted : March 23, 2011
Results First Posted : February 21, 2013
Last Update Posted : March 1, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Unigene Laboratories Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postmenopausal Osteoporosis
Interventions Drug: PTH analog
Drug: Placebo
Drug: Forsteo (Teriparatide)
Enrollment 97
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Forsteo (Teriparatide) PTH Analog Tablets Placebo
Hide Arm/Group Description Teriparatide : 20 mcg SC Injection, once daily. PTH analog : 5 mg tablets, once daily. Placebo : matching tablets, once daily
Period Title: Overall Study
Started 32 33 32
Completed 27 28 28
Not Completed 5 5 4
Reason Not Completed
Adverse Event             3             5             2
Withdrawal by Subject             2             0             2
Arm/Group Title Forsteo (Teriparatide) PTH Analog Tablets Placebo Total
Hide Arm/Group Description Teriparatide : 20 mcg SC Injection, once daily PTH analog : 5 mg tablets, once daily Placebo : matching tablets, once daily Total of all reporting groups
Overall Number of Baseline Participants 32 33 32 97
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 33 participants 32 participants 97 participants
66.5  (6.99) 67.4  (3.95) 66.1  (6.09) 66.7  (5.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 32 participants 97 participants
Female
32
 100.0%
33
 100.0%
32
 100.0%
97
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24
Hide Description [Not Specified]
Time Frame 24 weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.
Arm/Group Title Forsteo (Teriparatide) PTH Analog Tablets Placebo
Hide Arm/Group Description:
Teriparatide : 20 mcg SC Injection, once daily
PTH analog : 5 mg tablets, once daily
Placebo : matching tablets, once daily
Overall Number of Participants Analyzed 30 28 27
Mean (Standard Deviation)
Unit of Measure: percentage of change
5.07  (3.543) 2.21  (2.503) -0.17  (2.739)
2.Secondary Outcome
Title % Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24
Hide Description Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.
Time Frame 24 weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.
Arm/Group Title Forsteo (Teriparatide) PTH Analog Tablets Placebo
Hide Arm/Group Description:
Teriparatide : 20 mcg SC Injection, once daily
PTH analog : 5 mg tablets, once daily
Placebo : matching tablets, once daily
Overall Number of Participants Analyzed 30 28 28
Mean (Standard Deviation)
Unit of Measure: percentage of change
113.32  (102.932) 12.72  (36.547) 15.13  (23.940)
3.Secondary Outcome
Title Systemic Absorption of PTH at Week 24
Hide Description AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Forsteo (Teriparatide) PTH Analog Tablets
Hide Arm/Group Description:
Teriparatide : 20 mcg SC Injection, once daily
PTH analog : 5 mg tablets, once daily
Overall Number of Participants Analyzed 27 28
Mean (Standard Deviation)
Unit of Measure: pg* hr/mL
152  (65.7) 165  (180)
4.Secondary Outcome
Title % Change From Baseline in Bone Formation Marker (P1NP) at Week 24
Hide Description [Not Specified]
Time Frame 24 weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.
Arm/Group Title Forsteo (Teriparatide) PTH Analog Tablets Placebo
Hide Arm/Group Description:
Teriparatide : 20 mcg SC Injection, once daily
PTH analog : 5 mg tablets, once daily
Placebo : matching tablets, once daily
Overall Number of Participants Analyzed 30 28 28
Mean (Standard Deviation)
Unit of Measure: percentage of change
210.07  (202.613) 12.05  (37.055) -1.75  (27.459)
5.Post-Hoc Outcome
Title Number of Participants With AEs as a Measure of Safety and Tolerability
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Overall Summary of Adverse Events - Each subject with an event is counted only once although they may have several events.
Arm/Group Title Forsteo (Teriparatide) PTH Analog Tablets Placebo
Hide Arm/Group Description:
Teriparatide : 20 mcg SC Injection, once daily
PTH analog : 5 mg tablets, once daily
Placebo : matching tablets, once daily
Overall Number of Participants Analyzed 32 33 32
Measure Type: Number
Unit of Measure: participants
23 30 21
Time Frame All AEs were recorded in the CRF during the course of the study. Serious adverse events (SAEs) were reported to the Sponsor within 24 hours of awareness.
Adverse Event Reporting Description The occurrences of AEs were documented at each visit during the study.
 
Arm/Group Title Forsteo (Teriparatide) PTH Analog Tablets Placebo
Hide Arm/Group Description Teriparatide : 20 mcg SC Injection, once daily PTH analog : 5 mg tablets, once daily Placebo : matching tablets, once daily
All-Cause Mortality
Forsteo (Teriparatide) PTH Analog Tablets Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Forsteo (Teriparatide) PTH Analog Tablets Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/32 (3.13%)      2/33 (6.06%)      2/32 (6.25%)    
Cardiac disorders       
Atrial flutter  1  0/32 (0.00%)  0 1/33 (3.03%)  1 0/32 (0.00%)  0
Injury, poisoning and procedural complications       
Wrist fracture  1  0/32 (0.00%)  0 1/33 (3.03%)  1 0/32 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Gastric cancer  1  1/32 (3.13%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0
Nervous system disorders       
Headache  1  0/32 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1
Reproductive system and breast disorders       
Ovarian cyst  1  0/32 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Forsteo (Teriparatide) PTH Analog Tablets Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/32 (71.88%)      30/33 (90.91%)      21/32 (65.63%)    
Cardiac disorders       
Bradycardia  1  0/32 (0.00%)  0 3/33 (9.09%)  3 1/32 (3.13%)  1
Presyncope  1  0/32 (0.00%)  0 1/33 (3.03%)  1 2/32 (6.25%)  2
Syncope  1  0/32 (0.00%)  0 4/33 (12.12%)  4 0/32 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  1  0/32 (0.00%)  0 2/33 (6.06%)  2 0/32 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  2/32 (6.25%)  2 6/33 (18.18%)  6 2/32 (6.25%)  2
Abdominal pain upper  1  0/32 (0.00%)  0 13/33 (39.39%)  13 6/32 (18.75%)  6
Diarrhoea  1  0/32 (0.00%)  0 0/33 (0.00%)  0 2/32 (6.25%)  2
Nausea  1  3/32 (9.38%)  3 5/33 (15.15%)  5 2/32 (6.25%)  2
General disorders       
Fatigue  1  2/32 (6.25%)  2 0/33 (0.00%)  0 1/32 (3.13%)  1
Infections and infestations       
Nasopharyngitis  1  3/32 (9.38%)  3 3/33 (9.09%)  3 3/32 (9.38%)  3
Rhinitis  1  2/32 (6.25%)  2 1/33 (3.03%)  1 1/32 (3.13%)  1
Injury, poisoning and procedural complications       
Contusion  1  0/32 (0.00%)  0 1/33 (3.03%)  1 2/32 (6.25%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/32 (3.13%)  1 0/33 (0.00%)  0 2/32 (6.25%)  2
Back pain  1  3/32 (9.38%)  3 2/33 (6.06%)  2 1/32 (3.13%)  1
Muscle spasms  1  0/32 (0.00%)  0 1/33 (3.03%)  1 2/32 (6.25%)  2
Osteoarthritis  1  2/32 (6.25%)  2 1/33 (3.03%)  1 1/32 (3.13%)  1
Pain in extremity  1  3/32 (9.38%)  3 0/33 (0.00%)  0 2/32 (6.25%)  2
Nervous system disorders       
Headache  1  4/32 (12.50%)  4 3/33 (9.09%)  3 2/32 (6.25%)  2
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  1/32 (3.13%)  1 3/33 (9.09%)  3 0/32 (0.00%)  0
Vascular disorders       
Dizziness  1  3/32 (9.38%)  3 3/33 (9.09%)  3 2/32 (6.25%)  2
Hot flush  1  2/32 (6.25%)  2 1/33 (3.03%)  1 1/32 (3.13%)  1
Hypertension  1  1/32 (3.13%)  1 2/33 (6.06%)  2 1/32 (3.13%)  1
Hypotension  1  0/32 (0.00%)  0 4/33 (12.12%)  4 0/32 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nozer Mehta, PhD. Chief Scientific Officer
Organization: Unigene Laboratories, Inc.
Phone: (973) 265-1100
EMail: nmehta@unigene.com
Layout table for additonal information
Responsible Party: Unigene Laboratories Inc.
ClinicalTrials.gov Identifier: NCT01321723    
Other Study ID Numbers: UGL-OR1001
First Submitted: March 16, 2011
First Posted: March 23, 2011
Results First Submitted: December 12, 2012
Results First Posted: February 21, 2013
Last Update Posted: March 1, 2013