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| ID | Type | Description | Link |
|---|---|---|---|
| ACTIVExtend Trial | Other Identifier | Radius Health, Inc. | |
| 2012-002216-10 | EudraCT Number |
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The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).
To assess the long-term effect of the anabolic drug, abaloparatide-subcutaneous (SC) versus placebo in the prevention of bone fracture after cessation of treatment. Participants who completed the 18-month Double-Blind BA058-05-003 (ACTIVE) study (NCT02653417), after receiving abaloparatide-SC or placebo, were enrolled in this extension study to receive 70 mg of alendronate (bisphosphonate) weekly for an additional 24 months. Complete details for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alendronate | Experimental | Participants received 70 milligrams (mg) of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 micrograms (mcg) SC or abaloparatide-matching placebo daily for 18 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alendronate | Drug | Alendronate is a bisphosphonate drug that prevents bone resorption by osteoclast and is used for the treatment of osteoporosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline | Vertebral fractures were determined clinically and via protocol directed radiograph evaluation. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. | Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined) | Nonvertebral fractures were defined as clinical fractures that included: 1) those of the hip, wrist, forearm, shoulder, collar bone, upper arm, ribs, upper leg (not hip), knee, lower leg (not knee or ankle), foot, ankle, hand, pelvis (not hip), tailbone, and other; and 2) those associated with low trauma, defined as a fall from standing height or less; a fall on stairs, steps or curbs; a minimal trauma other than a fall; or moderate trauma other than a fall. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Mitlak | Radius Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakewood | Colorado | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28160873 | Result | Cosman F, Miller PD, Williams GC, Hattersley G, Hu MY, Valter I, Fitzpatrick LA, Riis BJ, Christiansen C, Bilezikian JP, Black D. Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial. Mayo Clin Proc. 2017 Feb;92(2):200-210. doi: 10.1016/j.mayocp.2016.10.009. | |
| 29800372 |
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The procedures performed for the Follow-up visit (Month 19) for Study 003 served as Baseline for Day 1 of Study BA058-05-005 (Study 005).
Eligible participants who received abaloparatide or placebo in the double-blind study (BA058-05-003 [Study 003]), were enrolled to this open-label extension study. Complete results for Study 003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abaloparatide-SC/Alendronate | Participants received 70 milligrams (mg) of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 micrograms (mcg) subcutaneous (SC) daily for 18 months. |
| FG001 |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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Even though this is an open-label study, participants and Investigators who will be participating in this study (BA058-05-005) will remain blinded to the prior treatment assignment in Study BA058-05-003 (NCT02653417) until all participants completed the first 6 months of BA058-05-005 for prespecified data analysis. Complete data analysis for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
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| Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
| Percent Change From Study BA058-05-003 Baseline in Total Hip BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Total hip BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. | Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
| Percent Change From Study BA058-05-003 Baseline in Femoral Neck BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Femoral neck BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. | Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
| Percent Change From Study BA058-05-003 Baseline in Lumbar Spine BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Lumbar spine BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. | Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
| Kaplan-Meier Estimated Event Rate of the First Incident of Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined) | Nonvertebral fractures were defined as clinical fractures that included: 1) those of the hip, wrist, forearm, shoulder, collar bone, upper arm, ribs, upper leg (not hip), knee, lower leg (not knee or ankle), foot, ankle, hand, pelvis (not hip), tailbone, and other; and 2) those associated with low trauma, defined as a fall from standing height or less; a fall on stairs, steps or curbs; a minimal trauma other than a fall; or moderate trauma other than a fall. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. | Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | A TEAE is any untoward medical occurrence or undesirable event(s) experienced in a participant that begins or worsens following administration of study drug, whether or not considered related to study drug by Investigator. A serious adverse event (SAE) was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason, death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), congenital anomaly/birth defect, or persistent or significant disability/incapacity. Intensity for each AE was defined as mild, moderate, or severe. AEs included both SAEs and non-serious AEs. AEs whose causal relation was characterized as Possible or Probable were considered as related to study drug. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA). A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 |
| Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Serum Chemistry laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: sodium (Low: ≤129; High: ≥148 milliequivalent per liter [mEq/L]), potassium (Low: ≤3.2; High: ≥5.5 mEq/L), albumin (<2.5 grams [g]/deciliter [dL]), total protein (<5 g/dL), glucose (Low: ≤54; High: >125 mg/dL [fasting] or >200 milligrams [mg]/dL [random]), creatinine (≥2.1 mg/dL), aspartate aminotransferase (AST) (≥5.1*upper limit of normal [ULN]), alanine aminotransferase (ALT) (≥5.1*ULN), alkaline phosphatase (AP) (≥3.1*ULN), total bilirubin (≥1.51*ULN [with any increase in liver function tests] ≥2.0*ULN [with normal liver function tests]), creatine kinase (≥3.1*ULN), total cholesterol (>226 mg/dL), and total calcium (Low: ≤7.4; High: ≥11.6 mg/dL). Only the serum chemistry parameters with at least 1 participant with a notable laboratory value are presented. | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 |
| Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Hematology laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Absolute Eosinophils (>5000 cells/mm^3), Absolute Lymphocytes (≤499 cells/mm^3), Absolute Neutrophils (≤999 cells/mm^3), % Eosinophils (>50%), % Lymphocytes (≤5%), % Neutrophils (≤10%), Hemoglobin (Low: ≤9.4 g/dL; High: change from baseline ≥2.1 g/dL), Platelets (≤99000 cells/mm^3), and White Blood Cells (Low: ≤1499 cells/mm^3; High: ≥20001 cells/mm^3). Only the hematology parameters with at least 1 participant with a notable laboratory value are presented. | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 |
| Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only) | Coagulation laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Activated Partial Thromboplastin Time (≥1.41*ULN), Prothrombin Time (≥1.21*ULN). Because the Activated Partial Thromboplastin Time was the only coagulation laboratory parameter with at least 1 participant with a notable laboratory value, this is the only parameter presented below. | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 |
| Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only) | Urine laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Glucose (2+), Protein (2+), Blood (>50 red blood cells per high-power field [rbc/hpf]). | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 |
| Hialeah |
| Florida |
| United States |
| Bethesda | Maryland | United States |
| Buenos Aires | Argentina |
| BrasÃlia | Brazil |
| Curitiba | Brazil |
| Rio de Janeiro | Brazil |
| São Paulo | Brazil |
| Vitória | Brazil |
| Brno | Czechia |
| Brno-Vinohrady | Czechia |
| Pardubice | Czechia |
| Aalborg | Denmark |
| Ballerup Municipality | Denmark |
| Vejle | Denmark |
| Tallinn | Estonia |
| Tartu | Estonia |
| Hong Kong | Hong Kong |
| Vilnius | Lithuania |
| Bialystok | Poland |
| Kielce | Poland |
| Lodz | Poland |
| Warsaw | Poland |
| Zgierz | Poland |
| Bucharest | Romania |
| Result |
| Bone HG, Cosman F, Miller PD, Williams GC, Hattersley G, Hu MY, Fitzpatrick LA, Mitlak B, Papapoulos S, Rizzoli R, Dore RK, Bilezikian JP, Saag KG. ACTIVExtend: 24 Months of Alendronate After 18 Months of Abaloparatide or Placebo for Postmenopausal Osteoporosis. J Clin Endocrinol Metab. 2018 Aug 1;103(8):2949-2957. doi: 10.1210/jc.2018-00163. |
| 36588166 | Derived | Cosman F, Hans D, Shevroja E, Wang Y, Mitlak B. Effect of Abaloparatide on Bone Microarchitecture Assessed by Trabecular Bone Score in Women With Osteoporosis: Post Hoc Analysis of ACTIVE and ACTIVExtend. J Bone Miner Res. 2023 Apr;38(4):464-470. doi: 10.1002/jbmr.4764. Epub 2023 Feb 12. |
| 32935170 | Derived | Watts NB, Dore RK, Baim S, Mitlak B, Hattersley G, Wang Y, Rozental TD, LeBoff MS. Forearm bone mineral density and fracture incidence in postmenopausal women with osteoporosis: results from the ACTIVExtend phase 3 trial. Osteoporos Int. 2021 Jan;32(1):55-61. doi: 10.1007/s00198-020-05555-1. Epub 2020 Sep 15. |
| 32665529 | Derived | Greenspan SL, Fitzpatrick LA, Mitlak B, Wang Y, Harvey NC, Deal C, Cosman F, McClung M. Abaloparatide followed by alendronate in women >/=80 years with osteoporosis: post hoc analysis of ACTIVExtend. Menopause. 2020 Oct;27(10):1137-1142. doi: 10.1097/GME.0000000000001593. |
| 32658264 | Derived | Cosman F, Peterson LR, Towler DA, Mitlak B, Wang Y, Cummings SR. Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial. J Clin Endocrinol Metab. 2020 Nov 1;105(11):3384-95. doi: 10.1210/clinem/dgaa450. |
| 31674644 | Derived | Leder BZ, Mitlak B, Hu MY, Hattersley G, Bockman RS. Effect of Abaloparatide vs Alendronate on Fracture Risk Reduction in Postmenopausal Women With Osteoporosis. J Clin Endocrinol Metab. 2020 Mar 1;105(3):938-43. doi: 10.1210/clinem/dgz162. |
| 31411768 | Derived | Leder BZ, Zapalowski C, Hu MY, Hattersley G, Lane NE, Singer AJ, Dore RK. Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial. J Bone Miner Res. 2019 Dec;34(12):2213-2219. doi: 10.1002/jbmr.3848. Epub 2019 Sep 11. |
| Placebo/Alendronate |
Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide-matching placebo daily for 18 months. |
|
| Study 003 ITT Population | This Intent-To-Treat (ITT) population included participants who were randomized into Study 003. |
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| Study 003 Modified ITT (mITT) Population | Study003 ITT participants with Study 003 pretreatment & postbaseline evaluable radiologic assessment |
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| Completed Study 003 |
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| Study 005 ITT Population | All Study 003 ITT participants who enrolled in Study 005 . |
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| Study 005 Safety Population | All Study 005 ITT participants who received 1 or more doses of alendronate. |
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| Study 005 mITT Population | Study 003 mITT participants with a Study 005 postbaseline evaluable radiologic test (spine X-ray) |
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| COMPLETED |
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| NOT COMPLETED |
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|
Study BA058-05-005 ITT Population: all Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study. Baseline Characteristics for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
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| ID | Title | Description |
|---|---|---|
| BG000 | Abaloparatide-SC/Alendronate | Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 mcg SC daily for 18 months. |
| BG001 | Placebo/Alendronate | Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide-matching placebo daily for 18 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Lumbar Spine Bone Mineral Density (BMD) T-Score | BMD data measured by a Dual Energy X-ray Absorptiometry (DXA) instrument manufactured by Lunar Prodigy or Hologic. At Baseline, participants were required to have a BMD T-score ≤2.5 to >-5.0 at the lumbar spine (L1-L4) or if the pre-specified fracture criteria were not met then T-score could be ≤3.0 to >-5.0. Osteoporosis status was based on the World Health Organization (WHO) 2007 criteria of normal (T-score >-1.0), osteopenia (T-score >-2.5 to ≤-1.0), and osteoporosis (T-score ≤-2.5). | All Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study (Study BA058-05-005 ITT Population) with an evaluable lumbar spine BMD T-score. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study. | Mean | Standard Deviation | T-score |
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| Femoral Neck BMD T-Score | BMD data measured by a DXA instrument manufactured by Lunar Prodigy or Hologic. At Baseline, participants were required to have a BMD T-score ≤2.5 to >-5.0 at the femoral neck or if the pre-specified fracture criteria were not met then T-score could be ≤3.0 to >-5.0. Osteoporosis status was based on the WHO 2007 criteria of normal (T-score >-1.0), osteopenia (T-score >-2.5 to ≤-1.0), and osteoporosis (T-score ≤-2.5). | All Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study (Study BA058-05-005 ITT Population) with an evaluable femoral neck BMD T-score. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study. | Mean | Standard Deviation | T-score |
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| Total Hip BMD T-Score | BMD data measured by a DXA instrument manufactured by Lunar Prodigy or Hologic. At Baseline, participants were required to have a BMD T-score ≤2.5 to >-5.0 at the femoral neck or if the pre-specified fracture criteria were not met then T-score could be ≤3.0 to >-5.0. Osteoporosis status was based on the WHO 2007 criteria of normal (T-score >-1.0), osteopenia (T-score >-2.5 to ≤-1.0), and osteoporosis (T-score ≤-2.5). | All Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study (Study BA058-05-005 ITT Population) with an evaluable femoral neck BMD T-score. Study BA058-05-003 ITT population included all participants who were randomized into the BA058-05-003 study. | Mean | Standard Deviation | T-score |
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| 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 | Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline | Vertebral fractures were determined clinically and via protocol directed radiograph evaluation. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. | Study BA058-05-005 mITT Population: all Study BA058-05-003 mITT participants with a Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) evaluable radiologic assessment (spine X-ray). Study BA058-05-003 mITT population included all ITT participants with a pretreatment and postbaseline evaluable radiologic assessment during Study BA058-05-003. | Posted | Count of Participants | Participants | Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
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| Secondary | Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined) | Nonvertebral fractures were defined as clinical fractures that included: 1) those of the hip, wrist, forearm, shoulder, collar bone, upper arm, ribs, upper leg (not hip), knee, lower leg (not knee or ankle), foot, ankle, hand, pelvis (not hip), tailbone, and other; and 2) those associated with low trauma, defined as a fall from standing height or less; a fall on stairs, steps or curbs; a minimal trauma other than a fall; or moderate trauma other than a fall. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. | Study BA058-05-005 ITT Population: all Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study. Study BA058-05-003 ITT population included all participants who were randomized into the study. | Posted | Count of Participants | Participants | Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
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| Secondary | Percent Change From Study BA058-05-003 Baseline in Total Hip BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Total hip BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. | Study BA058-05-005 ITT Population: all Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study. Study BA058-05-003 ITT population included all participants who were randomized into Study BA058-05-003. Missing BMD data were imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | percent change | Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
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| Secondary | Percent Change From Study BA058-05-003 Baseline in Femoral Neck BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Femoral neck BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. | Study BA058-05-005 ITT Population: all Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study. Study BA058-05-003 ITT population included all participants who were randomized into Study BA058-05-003. Missing BMD data were imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | percent change | Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
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| Secondary | Percent Change From Study BA058-05-003 Baseline in Lumbar Spine BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) | Lumbar spine BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. | Study BA058-05-005 ITT Population: all Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study. Study BA058-05-003 ITT population included all participants who were randomized into Study BA058-05-003. Missing BMD data were imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | percent change | Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
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| Secondary | Kaplan-Meier Estimated Event Rate of the First Incident of Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined) | Nonvertebral fractures were defined as clinical fractures that included: 1) those of the hip, wrist, forearm, shoulder, collar bone, upper arm, ribs, upper leg (not hip), knee, lower leg (not knee or ankle), foot, ankle, hand, pelvis (not hip), tailbone, and other; and 2) those associated with low trauma, defined as a fall from standing height or less; a fall on stairs, steps or curbs; a minimal trauma other than a fall; or moderate trauma other than a fall. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. | Study BA058-05-005 ITT Population: all Study BA058-05-003 ITT participants who enrolled in the BA058-05-005 study. Study BA058-05-003 ITT population included all participants who were randomized into the study. | Posted | Number | percentage of events | Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only) | A TEAE is any untoward medical occurrence or undesirable event(s) experienced in a participant that begins or worsens following administration of study drug, whether or not considered related to study drug by Investigator. A serious adverse event (SAE) was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason, death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), congenital anomaly/birth defect, or persistent or significant disability/incapacity. Intensity for each AE was defined as mild, moderate, or severe. AEs included both SAEs and non-serious AEs. AEs whose causal relation was characterized as Possible or Probable were considered as related to study drug. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA). A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. | Posted | Count of Participants | Participants | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 |
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| Secondary | Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only) | Serum Chemistry laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: sodium (Low: ≤129; High: ≥148 milliequivalent per liter [mEq/L]), potassium (Low: ≤3.2; High: ≥5.5 mEq/L), albumin (<2.5 grams [g]/deciliter [dL]), total protein (<5 g/dL), glucose (Low: ≤54; High: >125 mg/dL [fasting] or >200 milligrams [mg]/dL [random]), creatinine (≥2.1 mg/dL), aspartate aminotransferase (AST) (≥5.1*upper limit of normal [ULN]), alanine aminotransferase (ALT) (≥5.1*ULN), alkaline phosphatase (AP) (≥3.1*ULN), total bilirubin (≥1.51*ULN [with any increase in liver function tests] ≥2.0*ULN [with normal liver function tests]), creatine kinase (≥3.1*ULN), total cholesterol (>226 mg/dL), and total calcium (Low: ≤7.4; High: ≥11.6 mg/dL). Only the serum chemistry parameters with at least 1 participant with a notable laboratory value are presented. | All Study BA058-05-005 ITT participants who received 1 or more doses of alendronate (Study BA058-05-005 Safety Population) with available data for the respective serum chemistry parameter. Only participants with a notable laboratory value are presented. | Posted | Count of Participants | Participants | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 |
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| Secondary | Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only) | Hematology laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Absolute Eosinophils (>5000 cells/mm^3), Absolute Lymphocytes (≤499 cells/mm^3), Absolute Neutrophils (≤999 cells/mm^3), % Eosinophils (>50%), % Lymphocytes (≤5%), % Neutrophils (≤10%), Hemoglobin (Low: ≤9.4 g/dL; High: change from baseline ≥2.1 g/dL), Platelets (≤99000 cells/mm^3), and White Blood Cells (Low: ≤1499 cells/mm^3; High: ≥20001 cells/mm^3). Only the hematology parameters with at least 1 participant with a notable laboratory value are presented. | All Study BA058-05-005 ITT participants who received 1 or more doses of alendronate (Study BA058-05-005 Safety Population) with available data for the respective hematology parameter. Only participants with a notable laboratory value are presented. | Posted | Count of Participants | Participants | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 |
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| Secondary | Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only) | Coagulation laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Activated Partial Thromboplastin Time (≥1.41*ULN), Prothrombin Time (≥1.21*ULN). Because the Activated Partial Thromboplastin Time was the only coagulation laboratory parameter with at least 1 participant with a notable laboratory value, this is the only parameter presented below. | All Study BA058-05-005 ITT participants who received 1 or more doses of alendronate (Study BA058-05-005 Safety Population) with available data for the respective coagulation parameter. Only participants with a notable laboratory value are presented. | Posted | Count of Participants | Participants | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only) | Urine laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Glucose (2+), Protein (2+), Blood (>50 red blood cells per high-power field [rbc/hpf]). | All Study BA058-05-005 ITT participants who received 1 or more doses of alendronate (Study BA058-05-005 Safety Population) with available data for the respective urine laboratory parameter. Only participants with a notable laboratory value are presented. | Posted | Count of Participants | Participants | Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24 |
|
Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
Study BA058-05-005 Safety Population: all Study BA058-05-005 ITT participants who received 1 or more doses of alendronate. Serious and Non-Serious TEAEs are presented. Adverse events for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abaloparatide-SC/Alendronate | Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 mcg SC daily for 18 months. | 65 | 553 | 145 | 553 | ||
| EG001 | Placebo/Alendronate | Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide-matching placebo daily for 18 months. | 58 | 580 | 158 | 580 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Drug induced liver injury | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pericarditis infective | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Viral myositis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Ovarian epithelial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Vulval cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebellar ischaemia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebral thrombosis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Medical device removal | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| Nasal septal operation | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| Removal of internal fixation | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Temporal arteritis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Radius Head of Clinical Operations | Radius Health, Inc. | (617) 551-4700 |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| D050723 | Fractures, Bone |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
| 65 to <74 years |
|
| ≥75 years |
|
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| Participants |
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| Participants |
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| OG001 |
| Placebo/Alendronate |
Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide-matching placebo daily for 18 months. |
|
|
| OG001 | Placebo/Alendronate | Participants received 70 mg of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide-matching placebo daily for 18 months. |
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| Units |
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