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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This study is designed to provide information about the bone anabolic properties and absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.
The choice of a 24-week treatment period was based on published studies of PTH which demonstrate its potential to produce a statistically significant increase in BMD in patients with postmenopausal osteoporosis within that observation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTH analog tablet | Experimental | PTH(1-31) 5 mg tablet, once daily |
|
| Placebo | Placebo Comparator | Placebo matching tablet, once daily |
|
| Forsteo | Active Comparator | Forsteo (teriparatide) 20 mcg SC Injection, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTH analog | Drug | A recombinant 1-31 amino acid fragment of PTH. |
|
| Measure | Description | Time Frame |
|---|---|---|
| % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24 | 24 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| % Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24 | Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used. | 24 weeks from baseline |
| Systemic Absorption of PTH at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christence S Teglbjaerg, MD | CCBR | Principal Investigator |
| Bettina S Nedergaard, MD | CCBR | Principal Investigator |
| Peter Alexandersen, MD | CCBR | Principal Investigator |
| Ivo Valter, MD | CCBR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCBR | Aalborg | Denmark | ||||
| CCBR |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23234813 | Result | Henriksen K, Andersen JR, Riis BJ, Mehta N, Tavakkol R, Alexandersen P, Byrjalsen I, Valter I, Nedergaard BS, Teglbjaerg CS, Stern W, Sturmer A, Mitta S, Nino AJ, Fitzpatrick LA, Christiansen C, Karsdal MA. Evaluation of the efficacy, safety and pharmacokinetic profile of oral recombinant human parathyroid hormone [rhPTH(1-31)NH(2)] in postmenopausal women with osteoporosis. Bone. 2013 Mar;53(1):160-6. doi: 10.1016/j.bone.2012.11.045. Epub 2012 Dec 9. | |
| 23719683 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Forsteo (Teriparatide) | Teriparatide : 20 mcg SC Injection, once daily. |
| FG001 | PTH Analog Tablets | PTH analog : 5 mg tablets, once daily. |
| FG002 | Placebo | Placebo : matching tablets, once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Forsteo (Teriparatide) | Teriparatide : 20 mcg SC Injection, once daily |
| BG001 | PTH Analog Tablets | PTH analog : 5 mg tablets, once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24 | 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. | Posted | Mean | Standard Deviation | percentage of change | 24 weeks from baseline |
|
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.
The occurrences of AEs were documented at each visit during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Forsteo (Teriparatide) | Teriparatide : 20 mcg SC Injection, once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA V14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA V14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nozer Mehta, PhD. Chief Scientific Officer | Unigene Laboratories, Inc. | (973) 265-1100 | nmehta@unigene.com |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C101312 | parathyroid hormone (1-31) |
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Placebo | Drug |
|
| Forsteo (Teriparatide) | Drug | A recombinant 1-34 amino acid fragment of PTH. |
|
|
AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours) |
| 24 weeks |
| % Change From Baseline in Bone Formation Marker (P1NP) at Week 24 | 24 weeks from baseline |
| Ballerup Municipality |
| Denmark |
| CCBR | Vejle | Denmark |
| CCBR | Tallinn | Estonia |
| Derived |
| Sturmer A, Mehta N, Giacchi J, Cagatay T, Tavakkol R, Mitta S, Fitzpatrick L, Wald J, Trang J, Stern W. Pharmacokinetics of oral recombinant human parathyroid hormone [rhPTH(1-31)NH(2)] in postmenopausal women with osteoporosis. Clin Pharmacokinet. 2013 Nov;52(11):995-1004. doi: 10.1007/s40262-013-0083-4. |
| BG002 | Placebo | Placebo : matching tablets, once daily |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| Placebo |
Placebo : matching tablets, once daily |
|
|
| Post-Hoc | Number of Participants With AEs as a Measure of Safety and Tolerability | Overall Summary of Adverse Events - Each subject with an event is counted only once although they may have several events. | Posted | Number | participants | 24 weeks |
|
|
|
| Secondary | % Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24 | Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used. | 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. | Posted | Mean | Standard Deviation | percentage of change | 24 weeks from baseline |
|
|
|
| Secondary | Systemic Absorption of PTH at Week 24 | AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours) | Posted | Mean | Standard Deviation | pg* hr/mL | 24 weeks |
|
|
|
| Secondary | % Change From Baseline in Bone Formation Marker (P1NP) at Week 24 | 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. | Posted | Mean | Standard Deviation | percentage of change | 24 weeks from baseline |
|
|
|
| 1 |
| 32 |
| 23 |
| 32 |
| EG001 | PTH Analog Tablets | PTH analog : 5 mg tablets, once daily | 2 | 33 | 30 | 33 |
| EG002 | Placebo | Placebo : matching tablets, once daily | 2 | 32 | 21 | 32 |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA V14.0 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA V14.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA V14.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA V14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA V14.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA V14.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA V14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA V14.0 | Systematic Assessment |
|
| Dizziness | Vascular disorders | MedDRA V14.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA V14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA V14.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA V14.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA V14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA V14.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA V14.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA V14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA V14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA V14.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA V14.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA V14.0 | Systematic Assessment |
|
| Presyncope | Cardiac disorders | MedDRA V14.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA V14.0 | Systematic Assessment |
|
| Syncope | Cardiac disorders | MedDRA V14.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA V14.0 | Systematic Assessment |
|
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| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |