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CompletedNCT01674621Updated Jun 16, 2020Results posted

Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis

A Phase 2 interventional study of Abaloparatide Transdermal (50 mcg) and Abaloparatide Transdermal (100 mcg) in Post Menopausal Osteoporosis, sponsored by Radius Health, Inc.. Completed at 9 sites in 4 countries. Open to female participants aged Up to 85 Years. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Radius Health, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
Up to 85 Years
Sex
Female
01

Study summary

To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment.

02

Conditions studied

  • Post Menopausal Osteoporosis

Keywords

  • BA058
  • Abaloparatide-SC
  • abaloparatide
  • Abaloparatide-TD
  • Osteo
  • Osteoporosis
  • Transdermal
  • Patch
03

In context

Osteoporosis, Postmenopausal

337 studies on the registry are indexed under Osteoporosis, Postmenopausal; 29 are open to participants now.

This study's enrollment of 250 is above the median of 110 across 265 interventional studies indexed under Osteoporosis, Postmenopausal.

Browse Osteoporosis, Postmenopausal studies →

Lead sponsor

Radius Health, Inc. is the lead sponsor of 11 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.

04

Who can participate

Ages eligible
Up to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Postmenopausal woman, less than 85 years old.
  • BMD T-score ≤-2.5 of spine or hip (femoral neck) or ≤-2.0 with previous fracture (within 5 years).
  • Normal physical exam, vital signs, electrocardiogram (ECG), and medical history.
  • Laboratory tests within the normal range, including serum calcium, Vitamin D, parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase.

Exclusion criteria

Exclusion Criteria:

  • BMD T-score ≤-5.0 at the lumbar spine or hip.
  • History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis.
  • Significantly impaired renal function.
  • History of any cancer.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    Abaloparatide Transdermal (50 mcg)

    Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months

    Drug: Abaloparatide Transdermal (50 mcg)

  • Experimental
    Abaloparatide Transdermal (100 mcg)

    Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months

    Drug: Abaloparatide Transdermal (100 mcg)

  • Experimental
    Abaloparatide Transdermal (150 mcg)

    Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months

    Drug: Abaloparatide Transdermal (150 mcg)

  • Active comparator
    Abaloparatide Injection (80 mcg)

    Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months

    Drug: Abaloparatide Injection (80 mcg)

  • Placebo comparator
    Abaloparatide Transdermal Placebo (0 mcg)

    Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months

    Drug: Abaloparatide Placebo

Interventions

  • DrugAbaloparatide Transdermal (50 mcg)

    Abaloparatide Transdermal Microneedle Active Patch

    Also known as: BA058 Transdermal (50 mcg)

  • DrugAbaloparatide Transdermal (100 mcg)

    Abaloparatide Transdermal Microneedle Active Patch

    Also known as: BA058 Transdermal (100 mcg)

  • DrugAbaloparatide Transdermal (150 mcg)

    Abaloparatide Transdermal Microneedle Active Patch

    Also known as: BA058 Transdermal (150 mcg)

  • DrugAbaloparatide Injection (80 mcg)

    Abaloparatide Subcutaneous Injection

    Also known as: BA058 Injection (80 mcg)

  • DrugAbaloparatide Placebo

    Abaloparatide Transdermal Microneedle Placebo Patch

    Also known as: BA058 Placebo

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months

    Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.

    Time frame: Baseline, 6 Months

Secondary outcomes

  1. Percent Change From Baseline in BMD of Total Hip at 6 Months

    Percent change in BMD as specified by DXA scans of the total hip.

    Time frame: Baseline, 6 Months

  2. Percent Change From Baseline in BMD of Forearm at 6 Months

    Percent change in BMD as specified by DXA scans of the forearm.

    Time frame: Baseline, 6 Months

  3. Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months

    Time frame: Baseline, 6 Months

  4. Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months

    Time frame: Baseline, 6 Months

  5. Percent Change From Baseline in Serum Osteocalcin at 6 Months

    Time frame: Baseline, 6 Months

  6. Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months

    Time frame: Baseline, 6 Months

  7. Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months

    Time frame: Baseline, 6 Months

  8. Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)

    A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section.

    Time frame: Baseline up to 6 Months

  9. Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes

    Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

    Time frame: Baseline up to 7 Months

  10. Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result

    The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

    Time frame: Baseline up to 7 Months

  11. Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4

    Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9\*10\^9/liter \[L\]; Grade 4 \<1.0\*10\^9/L), platelets (Grade 3: 25.0-49.9\*10\^9/L; Grade 4: \<25.0\*10\^9/L), haemoglobin (Grade 3: 65.0-79.0 grams \[g\]/L or 4.0-4.9 mmol/L; Grade 4: \<65.0 g/L or \<4.0 millimole \[mmol\]/L), granulocytes/bands (Grade 3: 0.5-0.9\*10\^9/L; Grade 4: \<0.5\*10\^9/L), lymphocytes (Grade 3: 0.5-0.9\*10\^9/L; Grade 4: \<0.5 \*10\^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, \> 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

    Time frame: Baseline up to 6 Months

  12. Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4

    Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), \>1.0 g%, or \>10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0\*normal; Grade 4: \>6.0\*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units \[U\]/L\*normal, Grade 4: \>20.0 U/L\*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L\*normal; Grade 4: \>20.0 U/L\*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L\*normal; Grade 4: \>20.0 U/L\*normal), total bilirubin (Grade 3: 1.5-3.0\*normal; Grade 4: \>3.0\*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

    Time frame: Baseline up to 6 Months

  13. Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4

    Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%\*normal, Grade 4: \>2.00%\*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds \[sec\], Grade 4: \>3.00 secs\*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

    Time frame: Baseline up to 6 Months

07

Results

Posted Dec 19, 2016

Participant flow

Participant flow — Overall Study
MilestoneAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Started5051485150
Modified intent-to-treat population4746434946
Safety population5051475150
Completed4543414544
Not completed58766
Withdrew: Adverse event32551
Withdrew: Inability to complete study procedures00002
Withdrew: Severe abaloparatide-sc hypersensitivity00010
Withdrew: Withdrawal by subject25201
Withdrew: Other than specified01002

Outcome measures

PrimaryPercent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months

Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.

Time frame:
Baseline, 6 Months
Reported as:
Mean · Percent change
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months
Percent changeAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months1.87 ± 2.872.33 ± 2.962.95 ± 3.135.80 ± 4.210.04 ± 2.47
Statistical analysis
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.0066 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.0005 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = <0.0001 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -3.930 · 95% CI -5.555 to -2.305Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -3.470 · 95% CI -5.104 to -1.837Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -2.856 · 95% CI -4.519 to -1.193Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).
SecondaryPercent Change From Baseline in BMD of Total Hip at 6 Months

Percent change in BMD as specified by DXA scans of the total hip.

Time frame:
Baseline, 6 Months
Reported as:
Mean · Percent change
Percent Change From Baseline in BMD of Total Hip at 6 Months
Percent changeAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Percent Change From Baseline in BMD of Total Hip at 6 Months0.97 ± 1.951.32 ± 1.961.49 ± 1.732.74 ± 3.05-0.02 ± 2.39
Statistical analysis
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.0547 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.0056 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.0018 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -1.768 · 95% CI -2.864 to -0.672Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -1.420 · 95% CI -2.522 to -0.318Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -1.247 · 95% CI -2.368 to -0.126Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).
SecondaryPercent Change From Baseline in BMD of Forearm at 6 Months

Percent change in BMD as specified by DXA scans of the forearm.

Time frame:
Baseline, 6 Months
Reported as:
Mean · Percent change
Percent Change From Baseline in BMD of Forearm at 6 Months
Percent changeAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Percent Change From Baseline in BMD of Forearm at 6 Months-0.24 ± 2.74-0.16 ± 3.710.84 ± 2.960.33 ± 3.410.05 ± 3.18
Statistical analysis
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.9493 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.9806 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.5191 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -0.564 · 95% CI -2.168 to 1.040Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -0.483 · 95% CI -2.115 to 1.150Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): 0.517 · 95% CI -1.106 to 2.139Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
SecondaryPercent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
Time frame:
Baseline, 6 Months
Reported as:
Mean · Percent change
Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
Percent changeAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months-4.84 ± 23.875.22 ± 43.66-5.52 ± 37.8617.30 ± 42.7610.23 ± 64.93
Statistical analysis
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.2549 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.9115 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.2390 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -22.146 · 95% CI -40.501 to -3.790Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -12.086 · 95% CI -30.543 to 6.372Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -22.828 · 95% CI -41.614 to -4.041Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
SecondaryPercent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
Time frame:
Baseline, 6 Months
Reported as:
Mean · Percent change
Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
Percent changeAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months-17.26 ± 22.86-8.42 ± 29.51-16.63 ± 25.1110.28 ± 72.31-6.76 ± 31.35
Statistical analysis
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.1632 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.9834 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.2179 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment (EOT) to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -27.541 · 95% CI -48.557 to -6.525Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -18.702 · 95% CI -39.835 to 2.430Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -26.914 · 95% CI -48.424 to -5.405Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
SecondaryPercent Change From Baseline in Serum Osteocalcin at 6 Months
Time frame:
Baseline, 6 Months
Reported as:
Mean · Percent change
Percent Change From Baseline in Serum Osteocalcin at 6 Months
Percent changeAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Percent Change From Baseline in Serum Osteocalcin at 6 Months-4.37 ± 19.366.67 ± 33.38-3.83 ± 22.0169.54 ± 81.79-4.21 ± 27.55
Statistical analysis
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 1.0000 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.1200 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.9998 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -73.906 · 95% CI -96.926 to -50.886Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -62.872 · 95% CI -86.019 to -39.725Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -73.367 · 95% CI -96.927 to -49.807Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
SecondaryPercent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
Time frame:
Baseline, 6 Months
Reported as:
Mean · Percent change
Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
Percent changeAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months-12.76 ± 26.811.52 ± 57.29-6.78 ± 38.9197.64 ± 172.52-7.26 ± 35.49
Statistical analysis
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.8569 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.6091 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.9999 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of PINP from baseline to EOT to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -110.398 · 95% CI -156.966 to -63.831Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -96.115 · 95% CI -142.940 to -49.290Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -104.418 · 95% CI -152.079 to -56.758Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
SecondaryPercent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
Time frame:
Baseline, 6 Months
Reported as:
Mean · Percent change
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
Percent changeAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months-2.61 ± 28.771.65 ± 48.66-8.22 ± 54.8441.11 ± 104.129.42 ± 22.57
Statistical analysis
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.3483 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.6839 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Transdermal Placebo (0 mcg) · Dunnett's test · p = 0.1067 (Threshold for significance at 0.05 level.)P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.
  • Abaloparatide Transdermal (50 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -43.721 · 95% CI -75.748 to -11.694Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (100 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -39.461 · 95% CI -71.665 to -7.257Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
  • Abaloparatide Transdermal (150 mcg) vs Abaloparatide Injection (80 mcg) · Mean difference (final values): -49.334 · 95% CI -82.113 to -16.555Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
SecondaryNumber of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)

A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section.

Time frame:
Baseline up to 6 Months
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
ParticipantsAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
General appearance at Screening00010
General appearance at 6 months00110
Skin at Screening2824171421
Skin at 6 months2926161417
Head at Screening63251
Head at 6 months64342
Lungs at Screening00011
Lungs at 6 months00010
Breasts at Screening473311
Breasts at 6 months473410
Abdomen at Screening78494
Abdomen at 6 months67393
Lymph nodes at Screening00100
Lymph nodes at 6 months00001
Columna at Screening13741
Columna at 6 months12731
Extremities at Screening2113142321
Extremities at 6 months2310142521
Neurologic at Screening00021
Neurologic at 6 months00031
SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes

Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Time frame:
Baseline up to 7 Months
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes
ParticipantsAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Hypertension01000
Blood Pressure Increased00110
Heart Rate increased00100
Dyspnoea00010
Dizziness00010
SecondaryNumber of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result

The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Time frame:
Baseline up to 7 Months
Reported as:
Count of participants · Participants
Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result
ParticipantsAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result00120
SecondaryNumber of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4

Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9\*10\^9/liter \[L\]; Grade 4 \<1.0\*10\^9/L), platelets (Grade 3: 25.0-49.9\*10\^9/L; Grade 4: \<25.0\*10\^9/L), haemoglobin (Grade 3: 65.0-79.0 grams \[g\]/L or 4.0-4.9 mmol/L; Grade 4: \<65.0 g/L or \<4.0 millimole \[mmol\]/L), granulocytes/bands (Grade 3: 0.5-0.9\*10\^9/L; Grade 4: \<0.5\*10\^9/L), lymphocytes (Grade 3: 0.5-0.9\*10\^9/L; Grade 4: \<0.5 \*10\^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, \> 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Time frame:
Baseline up to 6 Months
Reported as:
Count of participants · Participants
Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4
ParticipantsAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 465415
SecondaryNumber of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4

Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), \>1.0 g%, or \>10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0\*normal; Grade 4: \>6.0\*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units \[U\]/L\*normal, Grade 4: \>20.0 U/L\*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L\*normal; Grade 4: \>20.0 U/L\*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L\*normal; Grade 4: \>20.0 U/L\*normal), total bilirubin (Grade 3: 1.5-3.0\*normal; Grade 4: \>3.0\*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Time frame:
Baseline up to 6 Months
Reported as:
Count of participants · Participants
Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
ParticipantsAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 410000
SecondaryNumber of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4

Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%\*normal, Grade 4: \>2.00%\*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds \[sec\], Grade 4: \>3.00 secs\*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Time frame:
Baseline up to 6 Months
Reported as:
Count of participants · Participants
Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
ParticipantsAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 400000

Adverse events

Collected over Baseline up to 7 Months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Abaloparatide Transdermal (50 mcg)—0/50 (0%)40/50 (80%)
Abaloparatide Transdermal (100 mcg)—2/51 (3.9%)40/51 (78.4%)
Abaloparatide Transdermal (150 mcg)—2/47 (4.3%)37/47 (78.7%)
Abaloparatide Injection (80 mcg)—4/51 (7.8%)41/51 (80.4%)
Abaloparatide Transdermal Placebo (0 mcg)—1/50 (2%)39/50 (78%)
Most frequent serious events
Most frequent serious events
EventAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
ColitisGastrointestinal disorders0/500/511/470/510/50
OsteoarthritisMusculoskeletal and connective tissue disorders0/500/511/471/510/50
Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/500/510/470/511/50
Coronary artery diseaseCardiac disorders0/500/510/471/510/50
Abdominal PainGastrointestinal disorders0/500/510/471/510/50
Radius fractureInjury, poisoning and procedural complications0/501/510/470/510/50
Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/500/510/471/510/50
Cervix carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/501/510/470/510/50
Most frequent other events
Showing 10 of 19
Most frequent other events
EventAbaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)
NasopharyngitisInfections and infestations11/5010/518/4713/519/50
DizzinessNervous system disorders2/502/513/478/511/50
NauseaGastrointestinal disorders2/503/516/473/512/50
HeadacheNervous system disorders2/502/515/475/515/50
Back painMusculoskeletal and connective tissue disorders1/504/513/473/515/50
Application site erythemaGeneral disorders4/505/514/470/512/50
InfluenzaInfections and infestations4/504/512/475/514/50
Application site pruritusGeneral disorders0/501/514/470/510/50
BronchitisInfections and infestations0/500/514/471/511/50
CystitisInfections and infestations2/500/514/471/511/50

Baseline characteristics

Modified Intent-to-Treat (mITT) population included randomized participants with pretreatment and end-of-treatment evaluable radiologic assessments.

Age, Continuous
Age, Continuous(years)Abaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)Total
Mean65.9 ± 4.8365.7 ± 5.2666.3 ± 6.4666.4 ± 5.4866.5 ± 7.2766.2 ± 5.87
Sex: Female, Male
Sex: Female, Male(Participants)Abaloparatide Transdermal (50 mcg)Abaloparatide Transdermal (100 mcg)Abaloparatide Transdermal (150 mcg)Abaloparatide Injection (80 mcg)Abaloparatide Transdermal Placebo (0 mcg)Total
Female4746434946231
Male000000
08

Study locations

9 sites
  • Lakewood, Colorado 80227, United States
  • Atlanta, Georgia 30319, United States
  • Bethesda, Maryland 20817, United States
  • Aalborg, Denmark
  • Ballerup Municipality, Denmark
  • Vejle, Denmark
  • Tallinn, Estonia
  • Lodz, Poland
  • Warsaw, Poland
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01674621
Lead sponsor
Radius Health, Inc.
Collaborators
Nordic Bioscience A/S
Responsible party
Sponsor
First posted
Aug 29, 2012
Start date
Sep 25, 2012
Primary completion
Aug 2, 2013
Completion
Aug 2, 2013
Results posted
Dec 19, 2016
Last update
Jun 16, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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