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CompletedNCT01343004ACTIVEUpdated Mar 1, 2017Results posted

Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

A Phase 3 interventional study of Placebo and BA058 80 mcg in Osteoporosis and Postmenopausal Osteoporosis, sponsored by Radius Health, Inc.. Completed at 28 sites in 10 countries. Open to female participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-03-01.

Sponsored by Radius Health, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,463
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
Female
01

Study summary

The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter international study to evaluate the efficacy and safety of BA058 (abaloparatide) 80 µg in the prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe osteoporosis.

02

Conditions studied

  • Osteoporosis
  • Postmenopausal Osteoporosis

Keywords

  • BA058
  • abaloparatide
  • Abaloparatide-SC
  • osteoporosis
  • postmenopausal
  • bone loss
  • ACTIVE
  • fracture
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 2,463 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

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.

04

Who can participate

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

Inclusion criteria

  • Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age (inclusive) with a diagnosis of osteoporosis
  • The women are to have a bone mineral density (BMD) T score ≤ -2.5 and > -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and > -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and > -5.0
  • Normal physical exam, vital signs, electrocardiogram (ECG) and medical history
  • Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase

Exclusion criteria

Exclusion Criteria:

  • History of more than 4 mild or moderate spine fractures or any severe fracture
  • Abnormality of the spine or hip that would prohibit assessment of bone mineral density (BMD)
  • Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such as Paget's disease) or a diagnosis of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
  • History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient
  • Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid (PTHrP)
  • Prior treatment with bisphosphonates, fluoride, or strontium within the past five years or treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months (except hormone replacement therapy)
  • Prior treatment with an investigational drug within the past 12 months
  • History of nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
2,463 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo identical in appearance to BA058 study drug

    Drug: Placebo

  • Experimental
    BA058 80 mcg (abaloparatide)

    Drug: BA058 80 mcg

  • Active comparator
    teriparatide

    Blinded until after randomization, then open-label

    Drug: teriparatide

Interventions

  • DrugPlacebo

    Placebo 0 mcg subcutaneous daily

  • DrugBA058 80 mcg

    BA058 80 mcg subcutaneous daily

    Also known as: abaloparatide, Abaloparatide-SC

  • Drugteriparatide

    teriparatide 20 mcg subcutaneous daily

    Also known as: Forteo, Forsteo

06

What researchers measure

Primary outcomes

  1. Number of Participants With New Vertebral Fractures at 18 Months

    Time frame: 18 months

Secondary outcomes

  1. Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months

    Time frame: Basline and 18 months

  2. Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18

    Time frame: Baseline and 18 months

  3. Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18

    Time frame: Baseline and 18 months

  4. Number of Participants With Non-vertebral Fractures at 18 Months

    Time frame: 18 months

  5. Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months

    Time frame: 18 months

07

Results

Posted Mar 1, 2017

Participant flow

Participant flow — Overall Study
MilestonePlaceboBA058 80 mcg (Abaloparatide)Teriparatide
Started821824818
Completed637606658
Not completed184218160

Outcome measures

PrimaryNumber of Participants With New Vertebral Fractures at 18 Months
Time frame:
18 months
Reported as:
Number · participants
Number of Participants With New Vertebral Fractures at 18 Months
participantsPlaceboBA058 80 mcg (Abaloparatide)Teriparatide
Number of Participants With New Vertebral Fractures at 18 Months3046
Statistical analysis
  • Placebo vs BA058 80 mcg (Abaloparatide) · Fisher Exact · p = <0.0001
  • Placebo vs Teriparatide · Fisher Exact · p = <0.0001
SecondaryPercent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months
Time frame:
Basline and 18 months
Reported as:
Mean · percent change from baseline
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months
percent change from baselinePlaceboBA058 80 mcg (Abaloparatide)Teriparatide
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months0.48 ± 3.829.20 ± 7.549.12 ± 6.28
Statistical analysis
  • Placebo vs BA058 80 mcg (Abaloparatide) · ANCOVA · p = <0.0001P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
  • Placebo vs Teriparatide · ANCOVA · p = <0.0001P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
  • BA058 80 mcg (Abaloparatide) vs Teriparatide · ANCOVA · p = 0.8155P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
SecondaryPercent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18
Time frame:
Baseline and 18 months
Reported as:
Mean · percent change
Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18
percent changePlaceboBA058 80 mcg (Abaloparatide)Teriparatide
Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18-0.08 ± 2.773.44 ± 3.512.81 ± 3.33
Statistical analysis
  • Placebo vs BA058 80 mcg (Abaloparatide) · ANCOVA · p = <0.0001P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
  • Placebo vs Teriparatide · ANCOVA · p = <0.0001P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
  • BA058 80 mcg (Abaloparatide) vs Teriparatide · ANCOVA · p = <0.0001P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
SecondaryPercent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18
Time frame:
Baseline and 18 months
Reported as:
Mean · percent change
Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18
percent changePlaceboBA058 80 mcg (Abaloparatide)Teriparatide
Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18-0.44 ± 3.572.90 ± 4.212.26 ± 3.57
Statistical analysis
  • Placebo vs BA058 80 mcg (Abaloparatide) · ANCOVA · p = <0.0001P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
  • Placebo vs Teriparatide · ANCOVA · p = <0.0001P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
  • BA058 80 mcg (Abaloparatide) vs Teriparatide · ANCOVA · p = 0.0004P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.
SecondaryNumber of Participants With Non-vertebral Fractures at 18 Months
Time frame:
18 months
Reported as:
Number · Participants
Number of Participants With Non-vertebral Fractures at 18 Months
ParticipantsPlaceboBA058 80 mcg (Abaloparatide)Teriparatide
Number of Participants With Non-vertebral Fractures at 18 Months331824
Statistical analysis
  • Placebo vs BA058 80 mcg (Abaloparatide) · Chi-squared · p = 0.0318
  • Placebo vs Teriparatide · Chi-squared · p = 0.2304
  • BA058 80 mcg (Abaloparatide) vs Teriparatide · Chi-squared · p = 0.3361
SecondaryNumber of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months
Time frame:
18 months
Reported as:
Number · Hypercalcemic events
Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months
Hypercalcemic eventsPlaceboBA058 80 mcg (Abaloparatide)Teriparatide
Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months51534

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—90/820 (11%)447/820 (54.5%)
BA058 80 mcg (Abaloparatide)—80/822 (9.7%)492/822 (59.9%)
Teriparatide—82/818 (10%)456/818 (55.7%)
Most frequent serious events
Showing 10 of 181
Most frequent serious events
EventPlaceboBA058 80 mcg (Abaloparatide)Teriparatide
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/8203/8226/818
OsteoarthritisMusculoskeletal and connective tissue disorders1/8203/8223/818
CystoceleReproductive system and breast disorders0/8200/8223/818
Abdominal painGastrointestinal disorders3/8201/8220/818
Femur fractureInjury, poisoning and procedural complications3/8200/8220/818
Meniscus injuryInjury, poisoning and procedural complications3/8200/8222/818
Back painMusculoskeletal and connective tissue disorders3/8202/8221/818
Ischaemic strokeNervous system disorders3/8200/8220/818
CholelithiasisHepatobiliary disorders0/8203/8221/818
GoitreEndocrine disorders1/8201/8222/818
Most frequent other events
Showing 10 of 14
Most frequent other events
EventPlaceboBA058 80 mcg (Abaloparatide)Teriparatide
HypercalciuriaRenal and urinary disorders74/82093/822102/818
DizzinessNervous system disorders50/82082/82259/818
Back painMusculoskeletal and connective tissue disorders81/82069/82258/818
ArthralgiaMusculoskeletal and connective tissue disorders80/82071/82270/818
Upper respiratory tract infectionInfections and infestations63/82068/82273/818
NauseaGastrointestinal disorders25/82068/82242/818
NasopharyngitisInfections and infestations66/82048/82252/818
HeadacheNervous system disorders49/82062/82251/818
HypertensionVascular disorders52/82059/82241/818
InfluenzaInfections and infestations39/82052/82234/818

Baseline characteristics

Intent-to-treat (ITT) Population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1.

Age, Continuous
Age, Continuous(years)PlaceboBA058 80 mcg (Abaloparatide)TeriparatideTotal
Mean68.7 ± 6.568.9 ± 6.568.8 ± 6.668.8 ± 6.5
Gender
Gender(Participants)PlaceboBA058 80 mcg (Abaloparatide)TeriparatideTotal
Female8218248182463
Male0000
08

Study locations

28 sites
  • Lakewood, Colorado, United States
  • Miami, Florida, United States
  • N. Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Bethesda, Maryland, United States
  • Buenos Aires, Argentina
  • Brasilia, Brazil
  • Curitiba, Brazil
  • Rio de Janeiro, Brazil
  • Sao Paolo, Brazil
  • Vitoria, Brazil
  • Brno, Czech Republic
  • Pardubice, Czech Republic
  • Prague, Czech Republic
  • Aalborg, Denmark
  • Ballerup, Denmark
  • Vejle, Denmark
  • Tallinn, Estonia
  • Tartu, Estonia
  • Hong Kong, Hong Kong
  • Vilnius, Lithuania
  • Bialystok, Poland
  • Katowice, Poland
  • Kielce, Poland
  • Lodz, Poland
  • Warszaw, Poland
  • Zgierz, Poland
  • Bucharest, Romania
09

References and documents

Publications

  • Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2. PubMed 34231877 ↗
  • 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. PubMed 32658264 ↗
  • Saag KG, Williams SA, Wang Y, Weiss RJ, Cauley JA. Effect of Abaloparatide on Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women with Osteoporosis at High Risk for Fracture. Clin Ther. 2020 Jun;42(6):1099-1107.e1. doi: 10.1016/j.clinthera.2020.04.012. Epub 2020 Jun 6. Erratum In: Clin Ther. 2020 Oct;42(10):2117. doi: 10.1016/j.clinthera.2020.10.001. PubMed 32513495 ↗
  • 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. Erratum In: J Clin Endocrinol Metab. 2020 Aug 1;105(8):dgaa301. doi: 10.1210/clinem/dgaa301. PubMed 31674644 ↗
  • 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. PubMed 31411768 ↗
  • Moreira CA, Fitzpatrick LA, Wang Y, Recker RR. Effects of abaloparatide-SC (BA058) on bone histology and histomorphometry: The ACTIVE phase 3 trial. Bone. 2017 Apr;97:314-319. doi: 10.1016/j.bone.2016.11.004. Epub 2016 Nov 5. PubMed 27826127 ↗
  • Cosman F, Hattersley G, Hu MY, Williams GC, Fitzpatrick LA, Black DM. Effects of Abaloparatide-SC on Fractures and Bone Mineral Density in Subgroups of Postmenopausal Women With Osteoporosis and Varying Baseline Risk Factors. J Bone Miner Res. 2017 Jan;32(1):17-23. doi: 10.1002/jbmr.2991. Epub 2016 Sep 28. PubMed 27612281 ↗
  • Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, Hu MY, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C; ACTIVE Study Investigators. Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial. JAMA. 2016 Aug 16;316(7):722-33. doi: 10.1001/jama.2016.11136. Erratum In: JAMA. 2017 Jan 24;317(4):442. doi: 10.1001/jama.2016.20139. PubMed 27533157 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01343004
Lead sponsor
Radius Health, Inc.
Responsible party
Sponsor
First posted
Apr 27, 2011
Start date
Apr 2011
Primary completion
Oct 2014
Completion
Oct 2014
Results posted
Mar 1, 2017
Last update
Mar 1, 2017

Study contacts

Radius Health, Inc.
study director · Radius Health, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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