A Phase 3 interventional study of Alendronate in Postmenopausal Osteoporosis, sponsored by Radius Health, Inc.. Completed at 25 sites in 10 countries. Open to female participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-12-11.
Sponsored by Radius Health, Inc. · Phase 3, Interventional, and Treatment
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 1,139 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Radius Health, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Alendronate
Alendronate is a bisphosphonate drug that prevents bone resorption by osteoclast and is used for the treatment of osteoporosis.
Also known as: Fosamax, Alendronate sodium
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.
Time frame: 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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 \[rbc/hpf\]).
Time frame: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24
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.
| Milestone | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| Started | 558 | 581 |
| Study 003 itt population | 824 | 821 |
| Study 003 modified itt (mitt) population | 690 | 711 |
| Completed study 003 | 606 | 637 |
| Study 005 itt population | 558 | 581 |
| Study 005 safety population | 553 | 580 |
| Study 005 mitt population | 544 | 568 |
| Completed | 499 | 506 |
| Not completed | 59 | 75 |
| Withdrew: Adverse event | 26 | 36 |
| Withdrew: Withdrawal by subject | 13 | 13 |
| Withdrew: Continuing significant deterioration | 9 | 3 |
| Withdrew: Refusal of treatment | 4 | 6 |
| Withdrew: Lost to follow-up | 3 | 4 |
| Withdrew: Death | 2 | 3 |
| Withdrew: Inability to complete study procedures | 1 | 7 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Hypersensitivity to alendronate | 0 | 1 |
| Withdrew: Other than specified | 0 | 2 |
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.
| Participants | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline | 3 | 25 |
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.
| Participants | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined) | 15 | 32 |
Total hip BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
| percent change | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| 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) | 5.4737 ± 3.9884 | 1.3698 ± 2.9712 |
Femoral neck BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
| percent change | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| 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) | 4.5113 ± 4.8042 | 0.4649 ± 3.7913 |
Lumbar spine BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
| percent change | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| 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) | 12.7921 ± 7.9790 | 3.5133 ± 4.2765 |
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.
| percentage of events | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| 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) | 2.7 | 5.6 |
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.
| Participants | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| TEAEs | 452 | 466 |
| TEAEs Related to Study Treatment | 85 | 80 |
| Severe TEAEs | 38 | 40 |
| Serious TEAEs | 65 | 58 |
| TEAEs Leading to Death | 0 | 2 |
| TEAEs Leading to Discontinuation | 30 | 36 |
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.
| Participants | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| Alkaline Phosphatase | 1 | 0 |
| Cholesterol Total | 75 | 73 |
| Creatine Kinase | 2 | 1 |
| Glucose (Fasting; High) | 22 | 18 |
| Glucose (Random) | 1 | 2 |
| Potassium (Low) | 1 | 3 |
| Potassium (High) | 4 | 3 |
| Sodium (Low) | 1 | 1 |
| Sodium (High) | 6 | 2 |
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.
| Participants | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| Absolute Lymphocytes | 15 | 11 |
| Lymphocytes (Absolute Count or Percentage) | 15 | 11 |
| Absolute Neutrophils | 0 | 2 |
| Neutrophils (Absolute Count or Percentage) | 0 | 2 |
| Hemoglobin (Low) | 7 | 2 |
| Hemoglobin (High) | 19 | 17 |
| Platelets | 1 | 0 |
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.
| Participants | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only) | 9 | 4 |
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 \[rbc/hpf\]).
| Participants | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| Glucose | 4 | 3 |
| Protein | 6 | 6 |
| Blood | 77 | 50 |
Collected over Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Abaloparatide-SC/Alendronate | — | 65/553 (11.8%) | 145/553 (26.2%) |
| Placebo/Alendronate | — | 58/580 (10%) | 158/580 (27.2%) |
| Event | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 5/553 | 4/580 |
| VertigoEar and labyrinth disorders | 4/553 | 1/580 |
| Transient ischaemic attackNervous system disorders | 4/553 | 0/580 |
| Acute myocardial infarctionCardiac disorders | 1/553 | 3/580 |
| Lower limb fractureInjury, poisoning and procedural complications | 1/553 | 3/580 |
| Angina pectorisCardiac disorders | 2/553 | 1/580 |
| Atrial fibrillationCardiac disorders | 2/553 | 1/580 |
| Wrist fractureInjury, poisoning and procedural complications | 2/553 | 2/580 |
| Back painMusculoskeletal and connective tissue disorders | 2/553 | 1/580 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/553 | 0/580 |
| Event | Abaloparatide-SC/Alendronate | Placebo/Alendronate |
|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 54/553 | 58/580 |
| Upper respiratory tract infectionInfections and infestations | 40/553 | 51/580 |
| Back painMusculoskeletal and connective tissue disorders | 36/553 | 34/580 |
| HypertensionVascular disorders | 27/553 | 33/580 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 23/553 | 31/580 |
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.
| Age, Customized(Participants) | Abaloparatide-SC/Alendronate | Placebo/Alendronate | Total |
|---|---|---|---|
| <65 years | 106 | 114 | 220 |
| 65 to <74 years | 351 | 370 | 721 |
| ≥75 years | 101 | 97 | 198 |
| Sex: Female, Male(Participants) | Abaloparatide-SC/Alendronate | Placebo/Alendronate | Total |
|---|---|---|---|
| Female | 558 | 581 | 1139 |
| Male | 0 | 0 | 0 |
| Lumbar Spine Bone Mineral Density (BMD) T-Score(T-score) | Abaloparatide-SC/Alendronate | Placebo/Alendronate | Total |
|---|---|---|---|
| Mean | -2.11 ± 0.997 | -2.87 ± 0.867 | -2.50 ± 1.008 |
| Femoral Neck BMD T-Score(T-score) | Abaloparatide-SC/Alendronate | Placebo/Alendronate | Total |
|---|---|---|---|
| Mean | -1.951 ± 0.656 | -2.196 ± 0.695 | -2.077 ± 0.687 |
| Total Hip BMD T-Score(T-score) | Abaloparatide-SC/Alendronate | Placebo/Alendronate | Total |
|---|---|---|---|
| Mean | -1.63 ± 0.742 | -1.93 ± 0.758 | -1.78 ± 0.765 |
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Radius Health, Inc.