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The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.
This is a randomized, parallel-group, multi-center, dose-finding study to evaluate the effects of BA058 in the treatment of otherwise healthy postmenopausal women with osteoporosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| BA058 20 µg | Experimental |
| |
| BA058 40 µg | Experimental |
| |
| BA058 80 µg | Experimental |
| |
| teriparatide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teriparatide | Drug | teriparatide 20 µg subcutaneous daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Marker of Bone Metabolism, PINP | PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth. | 6 months |
| Change in Bone Mineral Density, Total Spine. | Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Mineral Density, Femoral Neck. | Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24. | 6 months |
| Change in Bone Mineral Density, Total Hip. | Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24. |
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Primary Inclusion Criteria:
Primary Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Radius Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radius Health, Inc. | Cambridge | Massachusetts | 02139 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25393645 | Derived | Leder BZ, O'Dea LS, Zanchetta JR, Kumar P, Banks K, McKay K, Lyttle CR, Hattersley G. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015 Feb;100(2):697-706. doi: 10.1210/jc.2014-3718. Epub 2014 Nov 13. |
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After eligibility was established, patients entered a 4-week Pretreatment Period during which they received daily Calcium and Vitamin D supplements, were trained in self-injection with the pen devices, and were assessed for additional evaluations at the end of the Pretreatment Period. Patients who remained eligible were randomized on Day 1.
Recruitment for the study started in the US, in January 2007. For the initial 24-week treatment period, patients were randomized to study treatment at 30 study centers in the US, Argentina, India and the UK . Eleven of the 30 study centers treated patients in the 24-week treatment extension period in the US, Argentina, and India.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | |
| FG001 | BA058 20 µg | |
| FG002 | BA058 40 µg | |
| FG003 | BA058 80 µg | |
| FG004 | Teriparatide |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial 24 Weeks |
|
| ||||||||||||||||||
| Extended 24 Weeks of Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | |
| BG001 | BA058 20 µg | |
| BG002 | BA058 40 µg |
| 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 in Marker of Bone Metabolism, PINP | PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth. | The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 193 of the 221 ITT patients had data available for analysis at Week 24. | Posted | Mean | Standard Deviation | Percent change from baseline | 6 months |
|
For patients treated during the initial 6 months only, AEs were collected for 8 months (1 pre + 6 treatment + 1 post). For patients treated over the extended treatment period of 12 months, AEs were collected for 14 months (1 pre + 12 treatment + 1 post).
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
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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 | Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Program Director | Radius Health, Inc. | (617) 551-4700 | info@radiuspharm.com |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| C000596789 | abaloparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Placebo | Drug | Placebo subcutaneous daily |
|
| BA058 20 µg | Drug | BA058 20 µg subcutaneous daily |
|
| BA058 40 µg | Drug | BA058 40 µg subcutaneous daily |
|
| BA058 80 µg | Drug | BA058 80 µg subcutaneous daily |
|
| 6 months |
| Change in Bone Mineral Density, Total Spine. | Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48. | 12 months |
| Adverse Event |
|
| Inability to complete procedures |
|
| Lost to Follow-up |
|
| Non-compliance |
|
| Protocol Violation |
|
| Refusal of treatment |
|
| Other |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG003 | BA058 80 µg |
| BG004 | Teriparatide |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 |
| BA058 80 µg |
| OG004 | Teriparatide |
|
|
|
| Primary | Change in Bone Mineral Density, Total Spine. | Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24. | The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 187 of the 221 ITT patients had data available for analysis at Week 24. | Posted | Mean | Standard Deviation | Percent change from baseline | 6 months |
|
|
|
|
| Secondary | Change in Bone Mineral Density, Femoral Neck. | Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24. | The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24. | Posted | Mean | Standard Deviation | Percent change from baseline | 6 months |
|
|
|
| Secondary | Change in Bone Mineral Density, Total Hip. | Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24. | The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24. | Posted | Mean | Standard Deviation | Percent change from baseline | 6 months |
|
|
|
| Secondary | Change in Bone Mineral Density, Total Spine. | Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48. | The extension population included any patient who continued in the extended 24 weeks of treatment; N=55. 49 of the 55 extension patients had data available for analysis at Week 48. | Posted | Mean | Standard Deviation | Percent change from baseline | 12 months |
|
|
|
| 1 |
| 45 |
| 30 |
| 45 |
| EG001 | BA058 20 µg | 2 | 43 | 31 | 43 |
| EG002 | BA058 40 µg | 0 | 43 | 32 | 43 |
| EG003 | BA058 80 µg | 2 | 45 | 33 | 45 |
| EG004 | Teriparatide | 0 | 45 | 35 | 45 |
| Bronchitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Ovarian epithelial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Bilateral crural hernia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Injection site hematoma | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Injection site hemorrhage | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypercalciuria | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
The PI/Institution may publish/present results of the Study provided that the Publication is reviewed by the Sponsor for Confidential Information at least 60 days prior to submission. If the Publication contains patent-related information, the submission shall be delayed for 90 days.
The Institution/PI will not publish until after the data from the multi-center study is published in a combined paper as long as it is completed within 18 months from the date of study completion.
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
For the BMD endpoint, the planned study size has 80 percent power with alpha=0.02 to detect a difference in mean change from baseline of 3.0 (percent) in BMD for the BA058 group and the BA058 Placebo group using an assumed SD of 3.5-4.0. The estimates for SD are based upon results of lumbar spine BMD presented by Body 2002. |
| ANOVA |
| <0.001 |
| 0 |
| Superiority or Other |